Array ( [0] => {{Short description|Variant of a biopharmaceutical}} [1] => {{For|the journal|Biosimilars (journal)}} [2] => {{Use mdy dates|date=March 2024}} [3] => {{cs1 config |name-list-style=vanc |display-authors=6}} [4] => A '''biosimilar''' (also known as '''follow-on biologic''' or '''subsequent entry biologic''') is a [[biopharmaceutical|biologic medical product]] that is almost an identical copy of an original product that is manufactured by a different company.Blanchard, A., Helene D'Iorio and Robert Ford. "What you need to know to succeed: Key trends in Canada's biotech industry " Insights, Spring 2010 Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's [[chemical patent|patent]] expires. Reference to the innovator product is an integral component of the approval.{{cite web |url= https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf |title= Biosimilars in the EU: Information guide for healthcare professionals | work = European Medicines Agency and the European Commission | date = 2017 |archive-url=https://web.archive.org/web/20191015204916/https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf |archive-date=October 15, 2019}} [5] => [6] => Unlike with [[generic drug]]s of the more common [[small molecule|small-molecule]] type, biologics generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite that heterogeneity, all [[biopharmaceutical]]s, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle.{{cite journal | vauthors = Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, Seidl A, Schiestl M | title = Maintaining consistent quality and clinical performance of biopharmaceuticals | journal = Expert Opinion on Biological Therapy | volume = 18 | issue = 4 | pages = 369–379 | date = April 2018 | pmid = 29285958 | doi = 10.1080/14712598.2018.1421169 | doi-access = free }} [7] => [8] => Drug-related authorities such as the [[European Medicines Agency]] (EMA) of the European Union, the United States [[Food and Drug Administration]] (FDA), and the [[Health Products and Food Branch]] of [[Health Canada]] hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies demonstrate that the biological product is highly similar to the reference product, despite minor differences in clinically inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of [[immunogenicity]] and [[pharmacokinetics]] or [[pharmacodynamics]]). They are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and is intended to be used and for which licensure is sought for the biological product.{{citation needed|date=December 2021}} [9] => [10] => The [[World Health Organization]] (WHO) published its "Guidelines for the evaluation of similar biotherapeutic products (SBPs)" in 2009. The purpose of this guideline is to provide an international norm for evaluating biosimilars.{{cite report|url=https://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf|title=Guidelines on evaluation of similar Biotherapeutic Products (SBPs)|year=2009|publisher=[[World Health Organization]] (WHO)|access-date=October 24, 2019|archive-date=September 29, 2021|archive-url=https://web.archive.org/web/20210929201936/https://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf|url-status=dead}}{{cite report | title=Guidelines on evaluation of similar Biotherapeutic Products (SBPs), Annex 2, Technical Report Series No. 977 | publisher=[[World Health Organization]] (WHO) | year=2013 | url=https://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf?ua=1 | access-date=December 18, 2019 | archive-date=May 30, 2015 | archive-url=https://web.archive.org/web/20150530015521/http://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf?ua=1 | url-status=live }}{{cite report | title=WHO Questions and Answers: Similar Biotherapeutic Products | publisher=[[World Health Organization]] (WHO) | year=2018 | url=https://www.who.int/biologicals/expert_committee/QA_for_SBPs_ECBS_2018.pdf?ua=1 | access-date=December 18, 2019 | archive-date=April 21, 2019 | archive-url=https://web.archive.org/web/20190421035723/https://www.who.int/biologicals/expert_committee/QA_for_SBPs_ECBS_2018.pdf?ua=1 | url-status=live }}{{cite report | title=Guidelines on evaluation of monoclonal antibodies (mAbs) as similar biotherapeutic products (SBPs), Annex 2, Technical Report Series No. 1004 | publisher=[[World Health Organization]] (WHO) | year=2017 | url=https://www.who.int/biologicals/biotherapeutics/WHO_TRS_1004_web_Annex_2.pdf?ua=1 | access-date=December 18, 2019 | archive-date=April 14, 2021 | archive-url=https://web.archive.org/web/20210414054620/https://www.who.int/biologicals/biotherapeutics/WHO_TRS_1004_web_Annex_2.pdf?ua=1 | url-status=live }} [11] => [12] => The EMA has granted marketing authorizations for more than 50 biosimilars since 2006. The first biosimilar of a [[monoclonal antibody]] to be approved worldwide was a biosimilar of [[infliximab]] in the EU in 2013.{{cite web | title=Biosimilar medicines: Overview | website=[[European Medicines Agency]] (EMA) | date=September 17, 2018 | url=https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview | access-date=April 21, 2020 | archive-date=March 29, 2020 | archive-url=https://web.archive.org/web/20200329034341/https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview | url-status=live }} On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of [[filgrastim]] called filgrastim-sndz (trade name Zarxio) by [[Sandoz]]. [13] => [14] => ==Approval processes == [15] => [16] => ===United States=== [17] => In the United States, the [[Food and Drug Administration]] (FDA) held that new legislation was required to enable them to approve biosimilars to those biologics originally approved through the PHS Act pathway.{{cite web|url=http://judiciary.senate.gov/testimony.cfm?id=1239&wit_id=3623|title=US Senate Committee on the Judiciary, Testimony of Dr. Lester Crawford, Acting Commissioner, FDA June 23, 2004|access-date=October 8, 2007|archive-url=https://web.archive.org/web/20161228003407/http://www.judiciary.senate.gov/testimony.cfm?id=1239&wit_id=3623|archive-date=December 28, 2016|url-status=dead}} Additional Congressional hearings have been held.[http://energycommerce.house.gov/cmte_mtgs/110-he-hrg.050207.Biosimilar.shtml Hearing: Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States. Subcommittee on Health Wednesday, May 2, 2007] {{webarchive |url=https://web.archive.org/web/20070922194116/http://energycommerce.house.gov/cmte_mtgs/110-he-hrg.050207.Biosimilar.shtml |date=September 22, 2007 }} On March 17, 2009, the Pathway for Biosimilars Act was introduced in the House.{{cite journal |author=Nick, C |title=The US Biosimilars Act: Challenges Facing Regulatory Approval|journal=Pharm Med |volume=26 |issue=3 |pages=145–152 |year=2012 |doi=10.1007/bf03262388|s2cid=14604362}} Since 2004 the FDA has held a series of public meetings on biosimilars.{{cite web|url=https://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ucm085854.htm|archive-url=https://web.archive.org/web/20090709214850/http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ucm085854.htm|url-status=dead|archive-date=July 9, 2009|title=FDA page on "Follow-On Protein Products: Regulatory and Scientific Issues Related to Developing"|website=U.S. [[Food and Drug Administration]] (FDA)}}{{cite web|url=https://www.fda.gov/Drugs/NewsEvents/ucm221688.htm|archive-url=https://web.archive.org/web/20101007165215/http://www.fda.gov/Drugs/NewsEvents/ucm221688.htm|url-status=dead|archive-date=October 7, 2010|title=FDA page on "Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting"|website=U.S. [[Food and Drug Administration]] (FDA)}} [18] => [19] => The FDA gained the authority to approve biosimilars (including interchangeables that are substitutable with their reference product) as part of the [[Patient Protection and Affordable Care Act]] signed into law by President Obama on March 23, 2010.{{citation needed|date=December 2019}} [20] => [21] => The FDA has previously approved biologic products using comparability, for example, [[Omnitrope]] in May 2006, but this like [[Enoxaparin]] was also to a reference product, [[Genotropin]], originally approved as a [[biologic drug]] under the FD&C Act.{{cite web|url=https://www.fda.gov/ohrms/dockets/dockets/04P0231/04P-0231-pdn0001.pdf|title=FDA Response to three Citizen Petitions against biosimilars|website=U.S. [[Food and Drug Administration]] (FDA)|access-date=December 16, 2019|archive-date=May 31, 2017|archive-url=https://web.archive.org/web/20170531010155/https://www.fda.gov/ohrms/dockets/dockets/04p0231/04p-0231-pdn0001.pdf|url-status=live}} [22] => [23] => On March 6, 2015, [[Zarxio]] obtained the first approval of FDA.{{cite web|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm|archive-url=https://web.archive.org/web/20150307142645/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm|url-status=dead|archive-date=March 7, 2015|title=FDA page on "FDA approves first biosimilar product Zarxio"|website=U.S. [[Food and Drug Administration]] (FDA)}} Sandoz's Zarxio is biosimilar to Amgen's Neupogen (filgrastim), which was originally licensed in 1991. This is the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was passed as part of the Affordable Healthcare Act. But Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. And under the BPCI Act, only a biologic that has been approved as an "interchangeable" may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. The FDA said its approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates [[Zarxio]] is biosimilar to Neupogen.{{citation needed|date=December 2021}} [24] => [25] => In March 2020, most protein products that were approved as drug products (including every insulin currently on the market {{as of|December 2019|lc=yes}}) are scheduled to open up to biosimilar and interchangeable competition in the United States.{{cite web | title=Statement on low-cost biosimilar and interchangeable protein products | website=U.S. [[Food and Drug Administration]] (FDA) | date=December 17, 2019 | url=https://www.fda.gov/news-events/press-announcements/statement-low-cost-biosimilar-and-interchangeable-protein-products | archive-url=https://web.archive.org/web/20191218020741/https://www.fda.gov/news-events/press-announcements/statement-low-cost-biosimilar-and-interchangeable-protein-products | archive-date=December 18, 2019 | url-status=live | access-date=December 17, 2019}} {{PD-notice}} However, "chemically synthesized polypeptides" are excluded from this transition, which means that a product that falls within this category won't be able to come to market as a biosimilar or interchangeable product, but will have to come to the market under a different pathway. [26] => [27] => ==Background== [28] => Cloning of human genetic material and development of in vitro biological production systems has allowed the production of virtually any [[recombinant DNA]] based biological substance for eventual development of a drug. [[Monoclonal antibody]] technology combined with recombinant DNA technology has paved the way for tailor-made and targeted medicines. [[gene therapy|Gene-]] and [[cell therapy|cell-based]] therapies are emerging as new approaches. [29] => [30] => Recombinant therapeutic [[proteins]] are of a complex nature (composed of a long chain of amino acids, modified amino acids, derivatized by sugar moieties, folded by complex mechanisms). These proteins are made in living cells (bacteria, yeast, animal or human cell lines). The ultimate characteristics of a drug containing a recombinant therapeutic protein are to a large part determined by the process through which they are produced: choice of the cell type, development of the genetically modified cell for production, production process, purification process, formulation of the therapeutic protein into a drug. [31] => [32] => After the expiry of the patent of approved recombinant drugs (e.g., [[insulin]], human [[growth hormone]], [[interferons]], [[erythropoietin]], monoclonal antibodies and more) any other biotech company can develop and market these [[biologic medical product|biologics]] (thus called biosimilars). [33] => [34] => The typical reference product has undergone numerous changes in its manufacturing processes, and such changes in the manufacturing process (ranging from a change in the supplier of cell culture media to new purification methods or new manufacturing sites) was substantiated with appropriate data and was approved by the EMA. [35] => [36] => The current concept of development of biosimilar [[monoclonal antibody|mAbs]] follows the principle that an extensive state of the art physicochemical, analytical and functional comparison of the molecules is complemented by comparative non-clinical and clinical data that establish equivalent efficacy and safety in a clinical "model" indication that is most sensitive to detect any minor differences (if these exist) between the biosimilar and its reference mAb also at the clinical level. [37] => [38] => The EMA has recognized this fact, which has resulted in the establishment of the term "biosimilar" in recognition that, whilst biosimilar products are similar to the original product, they are not exactly the same.[http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf EMEA guideline on similar biological medicinal products] {{webarchive |url=https://web.archive.org/web/20070630132050/http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf |date=June 30, 2007 }} [39] => [40] => Originally the complexity of biological molecules led to requests for substantial efficacy and safety data for a biosimilar approval. This has been progressively replaced with a greater dependence on assays, from quality through to clinical, that show assay sensitivity sufficient to detect any significant difference in dose.{{cite journal | vauthors = Warren JB | title = Generics, chemisimilars and biosimilars: is clinical testing fit for purpose? | journal = British Journal of Clinical Pharmacology | volume = 75 | issue = 1 | pages = 7–14 | date = January 2013 | pmid = 22574725 | pmc = 3555041 | doi = 10.1111/j.1365-2125.2012.04323.x }} However, the safe application of biologics depends on an informed and appropriate use by healthcare professionals and patients. Introduction of biosimilars also requires a specifically designed [[pharmacovigilance]] plan. It is difficult and costly to recreate biologics because the complex proteins are derived from living organisms that are genetically modified. In contrast, small molecule drugs made up of a chemically based compound can be easily replicated and are considerably less expensive to reproduce. In order to be released to the public, biosimilars must be shown to be as close to identical to the parent innovator biologic product based on data compiled through clinical, animal, analytical studies and conformational status.{{cite journal|url = http://www.bioprocessintl.com/manufacturing/biosimilars/higher-order-structure-comparability/|title = Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies| vauthors = Wang X |date = June 1, 2014|journal = BioProcess International|issue = 6|volume = 12|pages = 32–37|access-date = August 13, 2014|archive-date = January 19, 2021|archive-url = https://web.archive.org/web/20210119031453/https://bioprocessintl.com/manufacturing/biosimilars/higher-order-structure-comparability/|url-status = live}}{{cite journal | vauthors = Declerck PJ | title = Biosimilar monoclonal antibodies: a science-based regulatory challenge | journal = Expert Opinion on Biological Therapy | volume = 13 | issue = 2 | pages = 153–6 | date = February 2013 | pmid = 23286777 | doi = 10.1517/14712598.2012.758710 | doi-access = free }} [41] => [42] => Generally, once a drug is released in the market by the FDA, it has to be re-evaluated for its safety and efficacy once every six months for the first and second years. Afterward, re-evaluations are conducted yearly, and the result of the assessment should be reported to authorities such as FDA. Biosimilars are required to undergo pharmacovigilance (PVG) regulations as its reference product. Thus biosimilars approved by the EMA are required to submit a risk management plan (RMP) along with the marketing application and have to provide regular safety update reports after the product is in the market. The RMP includes the safety profile of the drug and proposes the prospective pharmacovigilance studies. [43] => [44] => Several PK studies, such as studies conducted by Committee for Medicinal Products for Human Use (CHMP), have been conducted under various ranges of conditions; Antibodies from an originator's product versus antibodies from a biosimilar; combination therapy and monotherapy; various diseases, etc. on the purpose to verify comparability in pharmacokinetics of the biosimilar with the reference medicinal product in a sufficiently sensitive and homogeneous population. [45] => [46] => == Nomenclature == [47] => In the European Union, no unique identifier of a biosimilar medicine product is required, as the same rules are followed as for all biologics.{{citation needed|date=December 2021}} [48] => [49] => The US decided on a different approach, requiring the assignment of a four-letter suffix to the nonproprietary name of the original product to distinguish between innovator drugs and their biosimilars.{{cite web|title = Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability|url = https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonproprietary-naming-biological-products-update-guidance-industry|website = U.S. [[Food and Drug Administration]] (FDA)|access-date = August 2, 2018|archive-date = September 6, 2019|archive-url = https://web.archive.org/web/20190906175831/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonproprietary-naming-biological-products-update-guidance-industry|url-status = live}} Japan has similar requirements.{{cite journal | vauthors = Velásquez G |title=The International Debate on Generic Medicines of Biological Origin |journal=South Centre Policy Brief |date=August 2018 |issue=50 |url=https://www.southcentre.int/wp-content/uploads/2018/08/PB50_The-International-Debate-on-Generic-Medicines-of-Biological-Origin_EN.pdf |access-date=December 23, 2020 |archive-date=March 6, 2021 |archive-url=https://web.archive.org/web/20210306134448/https://www.southcentre.int/wp-content/uploads/2018/08/PB50_The-International-Debate-on-Generic-Medicines-of-Biological-Origin_EN.pdf |url-status=live }} The suffix approach has been criticized on the grounds of compromising the INN system and delaying the marketing of biosimilars. Australia decided not to use a 4-letter suffix.{{cite web | title=Australian Government Announces Decision on Biosimilar Naming Conventions | website=The Center For Biosimilars | date=January 31, 2018 | url=https://www.centerforbiosimilars.com/view/australian-government-announces-decision-on-biosimilar-naming-conventions | access-date=December 20, 2021 | archive-date=December 30, 2021 | archive-url=https://web.archive.org/web/20211230065202/https://www.centerforbiosimilars.com/view/australian-government-announces-decision-on-biosimilar-naming-conventions | url-status=live }}{{cite web | title=Biosimilar medicines regulation | website=Therapeutic Goods Administration (TGA) | date=April 4, 2018 | url=https://www.tga.gov.au/publication/biosimilar-medicines-regulation | access-date=December 29, 2021 | archive-date=December 30, 2021 | archive-url=https://web.archive.org/web/20211230065216/https://www.tga.gov.au/publication/biosimilar-medicines-regulation | url-status=live }}{{cite web | title=Which biosimilar medicines are available in Australia? | url=https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia | access-date=December 29, 2021 | archive-date=December 30, 2021 | archive-url=https://web.archive.org/web/20211230035404/https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia | url-status=live }} [50] => [51] => A version of the four-letter suffix has been proposed to the WHO as the biological qualifier (BQ). It is not part of the [[international nonproprietary name]] (INN), but is proposed to be managed under the same registry.{{cite web |title=Biological Qualifier |url=https://www.who.int/medicines/services/inn/inn_bio_bq/en/ |archive-url=https://web.archive.org/web/20150328123904/http://www.who.int/medicines/services/inn/inn_bio_bq/en/ |url-status=dead |archive-date=March 28, 2015 |website=WHO}} The report 1 of the May 2017 WHO Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products, published in October 2017, revealed on page 4, that following the outcome arising from the meeting: "No consensus was reached on whether WHO should continue with the BQ... WHO will not be proceeding with this at present."{{cite web|title = WHO Report on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products|url = https://www.who.int/medicines/access/biotherapeutics/FINAL_Report-improving-access-to-and-use-of-biotherapeutics_October2017.pdf|access-date = August 2, 2019|archive-date = October 31, 2017|archive-url = https://web.archive.org/web/20171031162408/http://www.who.int/medicines/access/biotherapeutics/FINAL_Report-improving-access-to-and-use-of-biotherapeutics_October2017.pdf|url-status = live}} [52] => [53] => == Australia == [54] => Biosimilars available in Australia include adalimumab, bevacizumab, enoxaparin, epoetin lambda, etanercept, filgrastim, follitropin alfa, infliximab, insulin aspart, insulin glargine, pegfilgrastim, rituximab, teriparatide, and trastuzumab.{{cite web | url=https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia | title=Which biosimilar medicines are available in Australia? | access-date=December 30, 2021 | archive-date=December 30, 2021 | archive-url=https://web.archive.org/web/20211230035404/https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia | url-status=live }} [55] => [56] => == Egypt == [57] => A research article about "Maximizing the benefits of using biosimilars in Egypt" proposed a regulatory framework for biosimilars in Egypt. The article summarized the recommendations of a number of stakeholders.{{cite journal | vauthors = Fasseeh AN, Elezbawy B, El-Fass KA, GamaI M, Seyam A, Hayek N, Abdel Rahman N, Abdelhamid S, Fasseeh N, Saad AS, Elagamy A, Mahmoud A, Sedrak AS, Elshazly K, Eldebeiky M, Talaat M, Mohamed NM, Abdelaziz RA, Refaat R, Akeel S, Abaza S, Kaló Z | title = Maximizing the benefits of using biosimilars in Egypt | journal = Journal of Pharmaceutical Policy and Practice | volume = 16 | issue = 1 | pages = 79 | date = June 2023 | pmid = 37365620 | pmc = 10291771 | doi = 10.1186/s40545-023-00581-w | doi-access = free }} [58] => [59] => ;Key Findings and Recommendations of the article [60] => # '''Pricing''': The experts suggested a mandatory discount of 30–40% on the price of the first biosimilar compared to its originator, with subsequent biosimilars receiving additional discounts. It was also recommended that biosimilar prices be revised periodically, either annually or biennially. [61] => # '''Reimbursement''': A significant emphasis was placed on using [[Health technology assessment|Health Technology Assessment]] (HTA), specifically cost-effectiveness analysis (CEA) and budget impact analysis (BIA), when manufacturers seek to extend reimbursement indications beyond those of the originator. Additionally, experts proposed that the first biosimilar, offering a minimum 50% discount compared to the originator, be granted immunity from removal from the formulary for a specified period. [62] => # '''Uptake''': The study highlighted the need for policies that enhance both prescriber and patient acceptance of biosimilars. Strategies include disseminating educational materials, implementing financial incentives for prescribing biosimilars as first-line therapy, and using co-payments to encourage the choice of less expensive biosimilars over more costly biologics. [63] => # '''Post-Marketing and Pharmacovigilance''': The importance of establishing registries and conducting real-world evidence studies to monitor biosimilar efficacy and safety was also emphasized. A pharmacovigilance framework specific to biosimilars and biologics was suggested to be more effective than the existing general framework. [64] => [65] => ==European Union== [66] => Biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.{{cite press release | title=Biosimilar medicines can be interchanged | website=[[European Medicines Agency]] (EMA) | date=September 19, 2022 | url=https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged | access-date=September 19, 2022 | archive-date=September 20, 2022 | archive-url=https://web.archive.org/web/20220920045913/https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged | url-status=live }} [67] => [68] => {| class="wikitable" [69] => |+European Union approved biosimilars{{cite web |title=EU Approved biosimilars by molecule [data arranged from EMA website] |url=https://www.biosimilars-nederland.nl/wp-content/uploads/2020_06_01-Table-EU-licensed-biosimilars-by-molecule_May_2020agv.pdf |website=Biosimilars Nederland |access-date=June 9, 2020 |archive-date=September 19, 2020 |archive-url=https://web.archive.org/web/20200919070220/https://www.biosimilars-nederland.nl/wp-content/uploads/2020_06_01-Table-EU-licensed-biosimilars-by-molecule_May_2020agv.pdf |url-status=live }} [70] => |- [71] => ! Active substance !! Reference product !! Biosimilar medicines [72] => |- [73] => | [[Adalimumab]] || Humira{{cite web | title=Humira EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/humira | access-date=March 7, 2024 | archive-date=February 18, 2020 | archive-url=https://web.archive.org/web/20200218190451/https://www.ema.europa.eu/en/medicines/human/EPAR/humira | url-status=live }} || Amgevita,{{cite web | title=Amgevita EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita | access-date=April 21, 2020 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230161340/https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita | url-status=live }} Amsparity,{{cite web | title=Amsparity EPAR | website=[[European Medicines Agency]] (EMA) | date=December 9, 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/amsparity | access-date=April 21, 2020 | archive-date=February 18, 2020 | archive-url=https://web.archive.org/web/20200218190500/https://www.ema.europa.eu/en/medicines/human/EPAR/amsparity | url-status=live }} Cyltezo,{{cite web | title=Cyltezo EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/cyltezo | access-date=August 27, 2021 | archive-date=August 6, 2020 | archive-url=https://web.archive.org/web/20200806180247/https://www.ema.europa.eu/en/medicines/human/EPAR/cyltezo | url-status=live }} Halimatoz,{{cite web | title=Halimatoz EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/halimatoz | access-date=April 21, 2020 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230161739/https://www.ema.europa.eu/en/medicines/human/EPAR/halimatoz | url-status=live }} Hefiya,{{cite web | title=Hefiya EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hefiya | access-date=April 21, 2020 | archive-date=October 15, 2019 | archive-url=https://web.archive.org/web/20191015195616/https://www.ema.europa.eu/en/medicines/human/EPAR/hefiya | url-status=live }} Hukyndra,{{cite web | title=Hukyndra EPAR | website=[[European Medicines Agency]] (EMA) | date=September 14, 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra | access-date=April 23, 2022 | archive-date=April 24, 2022 | archive-url=https://web.archive.org/web/20220424041728/https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra | url-status=live }} Hulio,{{cite web | title=Hulio EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hulio | access-date=April 21, 2020 | archive-date=March 24, 2020 | archive-url=https://web.archive.org/web/20200324055630/https://www.ema.europa.eu/en/medicines/human/EPAR/hulio | url-status=live }} Hyrimoz,{{cite web | title=Hyrimoz EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz | access-date=April 21, 2020 | archive-date=November 16, 2019 | archive-url=https://web.archive.org/web/20191116205930/https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz | url-status=live }} Idacio,{{cite web | title=Idacio EPAR | website=[[European Medicines Agency]] (EMA) | date=January 29, 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/idacio | access-date=April 21, 2020 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230161513/https://www.ema.europa.eu/en/medicines/human/EPAR/idacio | url-status=live }} Imraldi,{{cite web | title=Imraldi EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/imraldi | access-date=April 21, 2020 | archive-date=March 24, 2020 | archive-url=https://web.archive.org/web/20200324045318/https://www.ema.europa.eu/en/medicines/human/EPAR/imraldi | url-status=live }} Kromeya,{{cite web | title=Kromeya EPAR | website=[[European Medicines Agency]] (EMA) | date=January 29, 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/kromeya | access-date=August 27, 2021 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230161654/https://www.ema.europa.eu/en/medicines/human/EPAR/kromeya | url-status=live }} Libmyris,{{cite web | title=Libmyris EPAR | website=[[European Medicines Agency]] (EMA) | date=September 14, 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris | access-date=April 23, 2022 | archive-date=April 24, 2022 | archive-url=https://web.archive.org/web/20220424041731/https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris | url-status=live }} Solymbic,{{cite web | title=Solymbic EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/solymbic | access-date=August 27, 2021 | archive-date=June 25, 2019 | archive-url=https://web.archive.org/web/20190625133941/https://www.ema.europa.eu/en/medicines/human/EPAR/solymbic | url-status=live }} Trudexa,{{cite web | title=Trudexa EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/trudexa | access-date=August 27, 2021 | archive-date=February 18, 2020 | archive-url=https://web.archive.org/web/20200218190523/https://www.ema.europa.eu/en/medicines/human/EPAR/trudexa | url-status=live }} Yuflyma{{cite web | title=Yuflyma EPAR | website=[[European Medicines Agency]] (EMA) | date=December 9, 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma | access-date=August 27, 2021 | archive-date=August 28, 2021 | archive-url=https://web.archive.org/web/20210828065111/https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma | url-status=live }} [74] => |- [75] => | [[Bevacizumab]] || Avastin{{cite web | title=Avastin EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/avastin | access-date=September 11, 2021 | archive-date=March 18, 2020 | archive-url=https://web.archive.org/web/20200318210110/https://www.ema.europa.eu/en/medicines/human/EPAR/avastin | url-status=live }} || Abevmy,{{cite web | title=Abevmy EPAR | website=[[European Medicines Agency]] (EMA) | date=February 24, 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/abevmy | access-date=August 27, 2021 | archive-date=August 28, 2021 | archive-url=https://web.archive.org/web/20210828061650/https://www.ema.europa.eu/en/medicines/human/EPAR/abevmy | url-status=live }} Alymsys,{{cite web | title=Alymsys EPAR | website=[[European Medicines Agency]] (EMA) | date=January 25, 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/alymsys | access-date=September 11, 2021 | archive-date=October 8, 2021 | archive-url=https://web.archive.org/web/20211008120839/https://www.ema.europa.eu/en/medicines/human/EPAR/alymsys | url-status=live }} Aybintio,{{cite web | title=Aybintio EPAR | website=[[European Medicines Agency]] (EMA) | date=May 26, 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/aybintio | access-date=September 9, 2020 | archive-date=December 29, 2020 | archive-url=https://web.archive.org/web/20201229221338/https://www.ema.europa.eu/en/medicines/human/EPAR/aybintio | url-status=live }} Equidacent,{{cite web | title=Equidacent EPAR | website=[[European Medicines Agency]] (EMA) | date=July 20, 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/equidacent | access-date=October 12, 2020 | archive-date=October 13, 2020 | archive-url=https://web.archive.org/web/20201013000306/https://www.ema.europa.eu/en/medicines/human/EPAR/equidacent | url-status=live }} Mvasi,{{cite web | title=Mvasi EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/mvasi | access-date=April 2, 2020 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230161123/https://www.ema.europa.eu/en/medicines/human/EPAR/mvasi | url-status=live }} Onbevzi,{{cite web | title=Onbevzi EPAR | website=[[European Medicines Agency]] (EMA) | date=November 9, 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/onbevzi | access-date=September 11, 2021 | archive-date=November 5, 2021 | archive-url=https://web.archive.org/web/20211105130152/https://www.ema.europa.eu/en/medicines/human/EPAR/onbevzi | url-status=live }} Oyavas,{{cite web | title=Oyavas EPAR | website=[[European Medicines Agency]] (EMA) | date=January 25, 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/oyavas | access-date=September 11, 2021 | archive-date=October 8, 2021 | archive-url=https://web.archive.org/web/20211008175537/https://www.ema.europa.eu/en/medicines/human/EPAR/oyavas | url-status=live }} Vegzelma,{{cite web | title=Vegzelma EPAR | website=[[European Medicines Agency]] (EMA) | date=June 20, 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/vegzelma | access-date=March 3, 2023 | archive-date=January 28, 2023 | archive-url=https://web.archive.org/web/20230128020239/https://www.ema.europa.eu/en/medicines/human/EPAR/vegzelma | url-status=live }} Zirabev{{cite web | title=Zirabev EPAR | website=[[European Medicines Agency]] (EMA) | date=December 11, 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zirabev | access-date=April 2, 2020 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230160954/https://www.ema.europa.eu/en/medicines/human/EPAR/zirabev | url-status=live }} [76] => |- [77] => | [[Enoxaparin sodium]] || Clexane || Inhixa,{{cite web | title=Inhixa EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/inhixa | access-date=September 9, 2020 | archive-date=October 29, 2020 | archive-url=https://web.archive.org/web/20201029200312/https://www.ema.europa.eu/en/medicines/human/EPAR/inhixa | url-status=live }} Thorinane{{cite web | title=Thorinane EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/thorinane | access-date=April 2, 2020 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230161610/https://www.ema.europa.eu/en/medicines/human/EPAR/thorinane | url-status=live }} [78] => |- [79] => | [[Epoetin alfa]] || Eprex/Erypo || Abseamed,{{cite web | title=Abseamed EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/abseamed | access-date=April 4, 2022 | archive-date=March 23, 2020 | archive-url=https://web.archive.org/web/20200323234939/https://www.ema.europa.eu/en/medicines/human/EPAR/abseamed | url-status=live }} Binocrit,{{cite web | title=Binocrit EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/binocrit | access-date=April 4, 2022 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230161254/https://www.ema.europa.eu/en/medicines/human/EPAR/binocrit | url-status=live }} Epoetin Alfa Hexal,{{cite web | title=Epoetin Alfa Hexal EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/epoetin-alfa-hexal | access-date=April 4, 2022 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230162049/https://www.ema.europa.eu/en/medicines/human/EPAR/epoetin-alfa-hexal | url-status=live }} Retacrit,{{cite web | title=Retacrit EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/retacrit | access-date=April 4, 2022 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230161825/https://www.ema.europa.eu/en/medicines/human/EPAR/retacrit | url-status=live }} Silapo{{cite web | title=Silapo EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/silapo | access-date=April 4, 2022 | archive-date=October 22, 2020 | archive-url=https://web.archive.org/web/20201022043818/https://www.ema.europa.eu/en/medicines/human/EPAR/silapo | url-status=live }} [80] => |- [81] => | [[Etanercept]] || Enbrel{{cite web | title=Enbrel EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/enbrel | access-date=March 7, 2024 | archive-date=November 12, 2020 | archive-url=https://web.archive.org/web/20201112014334/https://www.ema.europa.eu/en/medicines/human/EPAR/enbrel | url-status=live }} || Benepali,{{cite web | title=Benepali EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/benepali | access-date=April 4, 2022 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230160905/https://www.ema.europa.eu/en/medicines/human/EPAR/benepali | url-status=live }} Erelzi,{{cite web | title=Erelzi EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/erelzi | access-date=April 4, 2022 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230160647/https://www.ema.europa.eu/en/medicines/human/EPAR/erelzi | url-status=live }} Lifmior,{{cite web | title=Lifmior EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lifmior | access-date=April 2, 2020}} Nepexto{{cite web | title=Nepexto EPAR | website=[[European Medicines Agency]] (EMA) | date=March 24, 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/nepexto | access-date=June 4, 2020 | archive-date=June 4, 2020 | archive-url=https://web.archive.org/web/20200604183709/https://www.ema.europa.eu/en/medicines/human/EPAR/nepexto | url-status=live }} [82] => |- [83] => | [[Filgrastim]] || Neupogen || Accofil,{{cite web | title=Accofil EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/accofil | access-date=April 4, 2022 | archive-date=March 23, 2020 | archive-url=https://web.archive.org/web/20200323235656/https://www.ema.europa.eu/en/medicines/human/EPAR/accofil | url-status=live }} Biograstim,{{cite web | title=Biograstim EPAR | website=[[European Medicines Agency]] (EMA) | date=September 17, 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/Biograstim | access-date=April 2, 2020 | archive-date=October 22, 2020 | archive-url=https://web.archive.org/web/20201022204309/https://www.ema.europa.eu/en/medicines/human/EPAR/biograstim | url-status=live }} Filgrastim Hexal,{{cite web | title=Filgrastim Hexal EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-hexal | access-date=April 4, 2022 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230161956/https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-hexal | url-status=live }} Filgrastim ratiopharm,{{cite web | title=Filgrastim ratiopharm EPAR | website=[[European Medicines Agency]] (EMA) | date=September 17, 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-ratiopharm | access-date=April 2, 2020 | archive-date=January 21, 2021 | archive-url=https://web.archive.org/web/20210121002356/https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-ratiopharm | url-status=live }} Grastofil,{{cite web | title=Grastofil EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/grastofil | access-date=April 4, 2022 | archive-date=November 12, 2020 | archive-url=https://web.archive.org/web/20201112002249/https://www.ema.europa.eu/en/medicines/human/EPAR/grastofil | url-status=live }} Nivestim,{{cite web | title=Nivestim EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/nivestim | access-date=April 4, 2022 | archive-date=December 20, 2019 | archive-url=https://web.archive.org/web/20191220191624/https://www.ema.europa.eu/en/medicines/human/EPAR/nivestim | url-status=live }} Ratiograstim,{{cite web | title=Ratiograstim EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ratiograstim | access-date=April 4, 2022 | archive-date=August 14, 2020 | archive-url=https://web.archive.org/web/20200814211722/https://www.ema.europa.eu/en/medicines/human/EPAR/ratiograstim | url-status=live }} Tevagrastim,{{cite web | title=Tevagrastim EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/tevagrastim | access-date=April 4, 2022 | archive-date=October 16, 2019 | archive-url=https://web.archive.org/web/20191016120016/https://www.ema.europa.eu/en/medicines/human/EPAR/tevagrastim | url-status=live }} Zarzio{{cite web | title=Zarzio EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio | access-date=April 4, 2022 | archive-date=October 15, 2019 | archive-url=https://web.archive.org/web/20191015190413/https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio | url-status=live }} [84] => |- [85] => | [[Follitropin alfa]] || Gonal-F{{cite web | title=Gonal-f EPAR | website=[[European Medicines Agency]] (EMA) | date=October 20, 1995 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/gonal-f | access-date=March 7, 2024 | archive-date=July 1, 2020 | archive-url=https://web.archive.org/web/20200701090155/https://www.ema.europa.eu/en/medicines/human/EPAR/gonal-f | url-status=live }} || Bemfola,{{cite web | title=Bemfola EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/bemfola | access-date=September 9, 2020 | archive-date=October 28, 2020 | archive-url=https://web.archive.org/web/20201028131041/https://www.ema.europa.eu/en/medicines/human/EPAR/bemfola | url-status=live }} Ovaleap{{cite web | title=Ovaleap EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ovaleap | access-date=September 9, 2020 | archive-date=September 23, 2020 | archive-url=https://web.archive.org/web/20200923142241/https://www.ema.europa.eu/en/medicines/human/EPAR/ovaleap | url-status=live }} [86] => |- [87] => | [[Infliximab]] || Remicade{{cite web | title=Remicade EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/remicade | access-date=March 7, 2024 | archive-date=October 22, 2020 | archive-url=https://web.archive.org/web/20201022094956/https://www.ema.europa.eu/en/medicines/human/EPAR/remicade | url-status=live }} || Flixabi,{{cite web | title=Flixabi EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/flixabi | access-date=April 4, 2022 | archive-date=October 16, 2019 | archive-url=https://web.archive.org/web/20191016120357/https://www.ema.europa.eu/en/medicines/human/EPAR/flixabi | url-status=live }} Inflectra,{{cite web | title=Inflectra EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/inflectra | access-date=April 4, 2022 | archive-date=October 16, 2019 | archive-url=https://web.archive.org/web/20191016115847/https://www.ema.europa.eu/en/medicines/human/EPAR/inflectra | url-status=live }} Remsima,{{cite web | title=Remsima EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/remsima | access-date=April 4, 2022 | archive-date=December 29, 2019 | archive-url=https://web.archive.org/web/20191229225040/https://www.ema.europa.eu/en/medicines/human/EPAR/remsima | url-status=live }} Zessly{{cite web | title=Zessly EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zessly | access-date=April 4, 2022 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230161426/https://www.ema.europa.eu/en/medicines/human/EPAR/zessly | url-status=live }} [88] => |- [89] => | [[Insulin aspart]] || NovoRapid{{cite web | title=NovoRapid EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/novorapid | access-date=March 7, 2024 | archive-date=September 22, 2023 | archive-url=https://web.archive.org/web/20230922163612/https://www.ema.europa.eu/en/medicines/human/EPAR/novorapid | url-status=live }} || Fiasp,{{cite web | title=Fiasp EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/Fiasp | access-date=August 27, 2021 | archive-date=August 28, 2021 | archive-url=https://web.archive.org/web/20210828065214/https://www.ema.europa.eu/en/medicines/human/EPAR/fiasp | url-status=live }} Insulin aspart Sanofi,{{cite web | title=Insulin aspart Sanofi EPAR | website=[[European Medicines Agency]] (EMA) | date=April 28, 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-aspart-sanofi | access-date=September 9, 2020 | archive-date=July 17, 2020 | archive-url=https://web.archive.org/web/20200717193355/https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-aspart-sanofi | url-status=live }} Kirsty,{{cite web | title=Kirsty EPAR | website=[[European Medicines Agency]] (EMA) | date=December 9, 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/kirsty-previously-kixelle | access-date=September 14, 2021 | archive-date=September 15, 2021 | archive-url=https://web.archive.org/web/20210915064025/https://www.ema.europa.eu/en/medicines/human/EPAR/kirsty-previously-kixelle | url-status=live }} NovoMix,{{cite web | title=NovoMix EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/NovoMix | access-date=August 27, 2021 | archive-date=April 13, 2020 | archive-url=https://web.archive.org/web/20200413050741/https://www.ema.europa.eu/en/medicines/human/EPAR/novomix | url-status=live }} Ryzodeg{{cite web | title=Ryzodeg EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/Ryzodeg | access-date=August 27, 2021 | archive-date=August 28, 2021 | archive-url=https://web.archive.org/web/20210828065133/https://www.ema.europa.eu/en/medicines/human/EPAR/ryzodeg | url-status=live }} [90] => |- [91] => | [[Insulin glargine]] || Lantus{{cite web | title=Lantus EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lantus | access-date=March 7, 2024 | archive-date=August 4, 2020 | archive-url=https://web.archive.org/web/20200804155233/https://www.ema.europa.eu/en/medicines/human/EPAR/lantus | url-status=live }} || Abasaglar,{{cite web | title=Abasaglar EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/abasaglar-previously-abasria | access-date=April 4, 2022 | archive-date=April 2, 2022 | archive-url=https://web.archive.org/web/20220402171234/https://www.ema.europa.eu/en/medicines/human/EPAR/abasaglar-previously-abasria | url-status=live }} Semglee{{cite web | title=Semglee EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/semglee | access-date=April 4, 2022 | archive-date=February 15, 2022 | archive-url=https://web.archive.org/web/20220215172501/https://www.ema.europa.eu/en/medicines/human/EPAR/semglee | url-status=live }} [92] => |- [93] => | [[Insulin lispro]] || Humalog{{cite web | title=Humalog EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/humalog | access-date=March 7, 2024 | archive-date=February 24, 2020 | archive-url=https://web.archive.org/web/20200224062204/https://www.ema.europa.eu/en/medicines/human/EPAR/humalog | url-status=live }} || Insulin lispro Sanofi{{cite web | title=Insulin lispro Sanofi EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-lispro-sanofi | access-date=September 9, 2020 | archive-date=February 24, 2020 | archive-url=https://web.archive.org/web/20200224062115/https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-lispro-sanofi | url-status=live }} [94] => |- [95] => | [[Pegfilgrastim]] || Neulasta{{cite web | title=Neulasta EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta | access-date=April 2, 2020 | archive-date=June 11, 2020 | archive-url=https://web.archive.org/web/20200611210847/https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta | url-status=live }} || Cegfila,{{cite web | title=Cegfila (previously Pegfilgrastim Mundipharma) EPAR | website=[[European Medicines Agency]] (EMA) | date=October 16, 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/cegfila | access-date=April 2, 2020 | archive-date=June 11, 2020 | archive-url=https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/cegfila | url-status=live }} Fulphila,{{cite web | title=Fulphila EPAR | website=[[European Medicines Agency]] (EMA) | date=September 24, 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila-0 | access-date=April 2, 2020 | archive-date=June 11, 2020 | archive-url=https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila-0 | url-status=live }} Grasustek,{{cite web | title=Grasustek EPAR | website=[[European Medicines Agency]] (EMA) | date=April 24, 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek | access-date=April 2, 2020 | archive-date=June 11, 2020 | archive-url=https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek | url-status=live }} Pelgraz,{{cite web | title=Pelgraz EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz | access-date=April 2, 2020 | archive-date=December 30, 2019 | archive-url=https://web.archive.org/web/20191230160459/https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz | url-status=live }} Pelmeg,{{cite web | title=Pelmeg EPAR | website=[[European Medicines Agency]] (EMA) | date=September 24, 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg | access-date=April 2, 2020 | archive-date=June 11, 2020 | archive-url=https://web.archive.org/web/20200611210918/https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg | url-status=live }} Udenyca,{{cite web | title=Udenyca | website=[[European Medicines Agency]] (EMA | url=https://www.ema.europa.eu/en/medicines/human/EPAR/udenyca | access-date=April 2, 2020 | archive-date=June 11, 2020 | archive-url=https://web.archive.org/web/20200611210836/https://www.ema.europa.eu/en/medicines/human/EPAR/udenyca | url-status=live }} Stimufend,{{cite web | title=Stimufend EPAR | website=[[European Medicines Agency]] (EMA) | date=January 24, 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend | access-date=April 4, 2022 | archive-date=April 21, 2022 | archive-url=https://web.archive.org/web/20220421083742/https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend | url-status=live }} Ziextenzo{{cite web | title=Ziextenzo EPAR | website=[[European Medicines Agency]] (EMA) | date=September 24, 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo | access-date=April 2, 2020 | archive-date=June 11, 2020 | archive-url=https://web.archive.org/web/20200611223851/https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo | url-status=live }} [96] => |- [97] => | [[Ranibizumab]] || Lucentis{{cite web | title=Lucentis EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lucentis | access-date=September 9, 2021 | archive-date=September 10, 2021 | archive-url=https://web.archive.org/web/20210910053245/https://www.ema.europa.eu/en/medicines/human/EPAR/lucentis | url-status=live }} || Byooviz,{{cite web | title=Byooviz EPAR | website=[[European Medicines Agency]] (EMA) | date=June 23, 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/byooviz | access-date=September 9, 2021 | archive-date=September 10, 2021 | archive-url=https://web.archive.org/web/20210910053259/https://www.ema.europa.eu/en/medicines/human/EPAR/byooviz | url-status=live }} Ranivisio,{{cite web | title=Ranivisio EPAR | website=[[European Medicines Agency]] (EMA) | date=June 20, 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ranivisio | access-date=October 6, 2022 | archive-date=October 6, 2022 | archive-url=https://web.archive.org/web/20221006034343/https://www.ema.europa.eu/en/medicines/human/EPAR/ranivisio | url-status=live }} Ximluci{{cite web | title=Ximluci EPAR | website=[[European Medicines Agency]] (EMA) | date=September 14, 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ximluci | access-date=March 3, 2023 | archive-date=March 13, 2023 | archive-url=https://web.archive.org/web/20230313235137/https://www.ema.europa.eu/en/medicines/human/EPAR/ximluci | url-status=live }} [98] => |- [99] => | [[Rituximab]] || MabThera{{cite web | title=MabThera EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/mabthera | access-date=September 8, 2021 | archive-date=September 9, 2021 | archive-url=https://web.archive.org/web/20210909063437/https://www.ema.europa.eu/en/medicines/human/EPAR/mabthera | url-status=live }} || Blitzima,{{cite web | title=Blitzima EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/blitzima | access-date=September 8, 2021 | archive-date=September 9, 2021 | archive-url=https://web.archive.org/web/20210909064129/https://www.ema.europa.eu/en/medicines/human/EPAR/blitzima | url-status=live }} Ritemvia,{{cite web | title=Ritemvia EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ritemvia | access-date=September 8, 2021 | archive-date=September 9, 2021 | archive-url=https://web.archive.org/web/20210909064151/https://www.ema.europa.eu/en/medicines/human/EPAR/ritemvia | url-status=live }} Rituzena,{{cite web | title=Rituzena EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/rituzena-previously-tuxella | access-date=September 8, 2021 | archive-date=September 9, 2021 | archive-url=https://web.archive.org/web/20210909064141/https://www.ema.europa.eu/en/medicines/human/EPAR/rituzena-previously-tuxella | url-status=live }} Rixathon,{{cite web | title=Rixathon EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/rixathon | access-date=September 8, 2021 | archive-date=September 9, 2021 | archive-url=https://web.archive.org/web/20210909064148/https://www.ema.europa.eu/en/medicines/human/EPAR/rixathon | url-status=live }} Riximyo,{{cite web | title=Riximyo EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/riximyo | access-date=September 8, 2021 | archive-date=September 9, 2021 | archive-url=https://web.archive.org/web/20210909064129/https://www.ema.europa.eu/en/medicines/human/EPAR/riximyo | url-status=live }} Ruxience,{{cite web | title=Ruxience EPAR | website=[[European Medicines Agency]] (EMA) | date=January 29, 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ruxience | access-date=September 8, 2021 | archive-date=September 9, 2021 | archive-url=https://web.archive.org/web/20210909064140/https://www.ema.europa.eu/en/medicines/human/EPAR/ruxience | url-status=live }} Truxima{{cite web | title=Truxima EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/truxima | access-date=September 8, 2021 | archive-date=September 9, 2021 | archive-url=https://web.archive.org/web/20210909064137/https://www.ema.europa.eu/en/medicines/human/EPAR/truxima | url-status=live }} [100] => |- [101] => | [[Somatropin]] || Genotropin || Omnitrope{{cite web | title=Omnitrope EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/omnitrope | access-date=April 2, 2020 | archive-date=July 27, 2020 | archive-url=https://web.archive.org/web/20200727011223/https://www.ema.europa.eu/en/medicines/human/EPAR/omnitrope | url-status=live }} [102] => |- [103] => | [[Teriparatide]] || Forsteo{{cite web | title=Forsteo EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/forsteo | access-date=March 7, 2024 | archive-date=June 27, 2020 | archive-url=https://web.archive.org/web/20200627011444/https://www.ema.europa.eu/en/medicines/human/EPAR/forsteo | url-status=live }} || Movymia,{{cite web | title=Movymia EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/movymia | access-date=April 4, 2022 | archive-date=May 1, 2022 | archive-url=https://web.archive.org/web/20220501163117/https://www.ema.europa.eu/en/medicines/human/EPAR/movymia | url-status=live }} Terrosa{{cite web | title=Terrosa EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/terrosa | access-date=April 4, 2022 | archive-date=August 14, 2019 | archive-url=https://web.archive.org/web/20190814064635/https://www.ema.europa.eu/en/medicines/human/EPAR/terrosa | url-status=live }} [104] => |- [105] => | [[Tocilizumab]] || RoActemra{{cite web | website=European Medicines Agency | title=RoActemra EPAR | date=January 16, 2009 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/roactemra | access-date=March 7, 2024 | archive-date=December 18, 2021 | archive-url=https://web.archive.org/web/20211218083546/https://www.ema.europa.eu/en/medicines/human/EPAR/roactemra | url-status=live }} || Tyenne{{cite web | title=Tyenne EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/tyenne | access-date=March 7, 2024 | archive-date=October 5, 2023 | archive-url=https://web.archive.org/web/20231005035054/https://www.ema.europa.eu/en/medicines/human/EPAR/tyenne | url-status=live }} [106] => |- [107] => | [[Trastuzumab]] || Herceptin{{cite web | title=Herceptin EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin | access-date=July 28, 2020 | archive-date=July 28, 2020 | archive-url=https://web.archive.org/web/20200728160341/https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin | url-status=live }} || Herzuma,{{cite web | title=Herzuma EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/herzuma | access-date=July 28, 2020 | archive-date=November 8, 2020 | archive-url=https://web.archive.org/web/20201108115519/https://www.ema.europa.eu/en/medicines/human/EPAR/herzuma | url-status=live }} Kanjinti,{{cite web | title=Kanjinti EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/kanjinti | access-date=July 28, 2020 | archive-date=October 31, 2020 | archive-url=https://web.archive.org/web/20201031025524/https://www.ema.europa.eu/en/medicines/human/EPAR/kanjinti | url-status=live }} Ogivri,{{cite web | title=Ogivri EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ogivri | access-date=July 28, 2020 | archive-date=March 24, 2020 | archive-url=https://web.archive.org/web/20200324053621/https://www.ema.europa.eu/en/medicines/human/EPAR/ogivri | url-status=live }} Ontruzant,{{cite web | title=Ontruzant EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ontruzant | access-date=July 28, 2020 | archive-date=August 4, 2020 | archive-url=https://web.archive.org/web/20200804092326/https://www.ema.europa.eu/en/medicines/human/EPAR/ontruzant | url-status=live }} Trazimera,{{cite web | title=Trazimera EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/trazimera | access-date=July 28, 2020 | archive-date=July 28, 2020 | archive-url=https://web.archive.org/web/20200728155022/https://www.ema.europa.eu/en/medicines/human/EPAR/trazimera | url-status=live }} Zercepac{{cite web | title=Zercepac EPAR | website=[[European Medicines Agency]] (EMA) | date=May 26, 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac | access-date=July 28, 2020 | archive-date=July 28, 2020 | archive-url=https://web.archive.org/web/20200728160454/https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac | url-status=live }} [108] => |} [109] => [110] => == United States == [111] => [112] => ===BPCI Act=== [113] => The [[Biologics Price Competition and Innovation Act of 2009|Biologics Price Competition and Innovation Act]] of 2009 (BPCI Act) was originally sponsored and introduced on June 26, 2007, by Senator [[Ted Kennedy|Edward Kennedy]] (D-MA). It was formally passed under the [[Patient Protection and Affordable Care Act]] (PPAC Act), signed into law by President Barack Obama on March 23, 2010. The BPCI Act was an amendment to the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to a [[Food and Drug Administration]] (FDA) approved biological product.{{cite web | title=Biosimilars | website=U.S. Food and Drug Administration | date=July 27, 2021 | url=https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars | access-date=August 28, 2021 | archive-date=August 28, 2021 | archive-url=https://web.archive.org/web/20210828185757/https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars | url-status=live }} {{PD-notice}} The BPCI Act is similar, conceptually, to the Drug Price Competition and Patent Term Restoration Act of 1984 (also referred to as the "Hatch-Waxman Act") which created biological drug approval through the Federal Food, Drug, and Cosmetic Act (FFD&C Act). The BPCI Act aligns with the FDA's longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. The FDA has released a total of four draft guidelines related to biosimilar or follow-on biologics development. Upon the release of the first three guidance documents the FDA held a public hearing on May 11, 2012.{{cite journal | vauthors = Epstein MS, Ehrenpreis ED, Kulkarni PM | title = Biosimilars: the need, the challenge, the future: the FDA perspective | journal = The American Journal of Gastroenterology | volume = 109 | issue = 12 | pages = 1856–9 | date = December 2014 | pmid = 24957160 | doi = 10.1038/ajg.2014.151 | s2cid = 19274464 | url = http://gi.org/wp-content/uploads/2015/01/FDA_Biosimilars_December_2014.pdf | access-date = September 25, 2016 | archive-url = https://web.archive.org/web/20161006151227/http://gi.org/wp-content/uploads/2015/01/FDA_Biosimilars_December_2014.pdf | archive-date = October 6, 2016 | url-status = dead }} [114] => [115] => In 2018, the FDA released a Biosimilars Action Plan to implement regulations from the BPCI, including limiting the abuse of the Risk Evaluation and Mitigation Strategy (REMS) system for [[evergreening]] and transitioning insulin and human growth hormone to regulation as biologics rather than drugs.{{cite press release|url=https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-actions-advancing-agencys-biosimilars-policy|title=Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency's biosimilars policy framework|website=U.S. [[Food and Drug Administration]] (FDA)|date=December 11, 2018|access-date=December 16, 2018|archive-date=May 8, 2019|archive-url=https://web.archive.org/web/20190508131837/https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-actions-advancing-agencys-biosimilars-policy|url-status=live}} [116] => [117] => ===US approved biosimilars=== [118] => [119] => {| class="wikitable" [120] => |- [121] => ! Date of Biosimilar FDA Approval !! Biosimilar Product{{cite web | title=Biosimilar Drug Information | publisher=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.fda.gov/drugs/biosimilars/biosimilar-product-information | access-date=August 28, 2021 | archive-date=August 28, 2021 | archive-url=https://web.archive.org/web/20210828185647/https://www.fda.gov/drugs/biosimilars/biosimilar-product-information | url-status=live }} {{PD-notice}} !! Original Product [122] => |- [123] => | March 2015{{cite web | title=Zarxio (filgrastim-sndz) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=April 20, 2015 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 20, 2019 | archive-url=https://web.archive.org/web/20191220184811/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm | url-status=live }} || filgrastim-sndz/Zarxio || [[filgrastim]]/Neupogen [124] => |- [125] => | April 2016{{cite web | title=Inflectra (infliximab-dyyb) for Injection | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=June 27, 2016 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125544Orig1s000TOC.cfm | access-date=November 26, 2023 | archive-date=May 20, 2022 | archive-url=https://web.archive.org/web/20220520044426/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125544Orig1s000TOC.cfm | url-status=live }} || infliximab-dyyb/Inflectra || [[infliximab]]/Remicade [126] => |- [127] => | August 2016{{cite press release|url=https://www.fda.gov/news-events/press-announcements/fda-approves-erelzi-biosimilar-enbrel|title=FDA approves Erelzi, a biosimilar to Enbrel|publisher=U.S. [[Food and Drug Administration]] (FDA)|access-date=December 17, 2020|archive-date=August 28, 2021|archive-url=https://web.archive.org/web/20210828185803/https://www.fda.gov/news-events/press-announcements/fda-approves-erelzi-biosimilar-enbrel|url-status=live}}{{cite web | title=Drug Approval Package: Erelzi (etanercept-szzs) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=October 25, 2016 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761042Orig1_toc.cfm | access-date=November 26, 2023 | archive-date=December 5, 2022 | archive-url=https://web.archive.org/web/20221205013037/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761042Orig1_toc.cfm | url-status=live }} || etanercept-szzs/Erelzi || [[etanercept]]/Enbrel [128] => |- [129] => | September 2016{{cite press release |url=https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira |title=FDA approves Amjevita, a biosimilar to Humira |publisher=U.S. [[Food and Drug Administration]] (FDA) |access-date=December 17, 2020 |archive-date=November 19, 2019 |archive-url=https://web.archive.org/web/20191119015605/https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira |url-status=live }}{{cite web | title=Drug Approval Package: Amjevita (adalimumab-atto) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=November 9, 2016 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024_toc.cfm | access-date=November 26, 2023 | archive-date=October 4, 2020 | archive-url=https://web.archive.org/web/20201004023112/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024_toc.cfm | url-status=live }} || adalimumab-atto/Amjevita || [[adalimumab]]/Humira [130] => |- [131] => | April 2017{{cite web | title=Drug Approval Package: Renflexis (infliximab-abda) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=December 10, 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761054Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218044927/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761054Orig1s000TOC.cfm | url-status=live }} || infliximab-abda/Renflexis || [[infliximab]]/Remicade [132] => |- [133] => | August 2017{{cite web|url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761058|title=Cyltezo: FDA Approved Drug Products|publisher=U.S. [[Food and Drug Administration]] (FDA)|access-date=August 28, 2017|archive-date=February 18, 2020|archive-url=https://web.archive.org/web/20200218192541/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761058|url-status=live}} || adalimumab-adbm/Cyltezo || [[adalimumab]]/Humira [134] => |- [135] => | September 2017{{cite press release|url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-cancer|title=FDA approves first biosimilar for the treatment of cancer|publisher=U.S. [[Food and Drug Administration]] (FDA)|access-date=December 17, 2020|archive-date=November 5, 2021|archive-url=https://web.archive.org/web/20211105130151/https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-cancer|url-status=live}}{{cite web | title=Drug Approval Package: Mvasi (bevacizumab-awwb) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=October 10, 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761028Orig1s000TOC.cfm | access-date=November 26, 2023 | archive-date=February 23, 2023 | archive-url=https://web.archive.org/web/20230223062038/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761028Orig1s000TOC.cfm | url-status=live }} || bevacizumab-awwb/Mvasi || [[bevacizumab]]/Avastin [136] => |- [137] => | December 2017{{cite press release |url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-certain-breast-and-stomach-cancers |title=FDA approves first biosimilar for the treatment of certain breast and stomach cancers |publisher=U.S. [[Food and Drug Administration]] (FDA) |access-date=December 17, 2020 |archive-date=December 15, 2019 |archive-url=https://web.archive.org/web/20191215091513/https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-certain-breast-and-stomach-cancers |url-status=live }}{{cite web | title=Drug Approval Package: Ogivri (Trastuzumab-dkst) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=November 29, 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761074Orig1s000TOC.cfm | access-date=November 26, 2023 | archive-date=March 22, 2023 | archive-url=https://web.archive.org/web/20230322101250/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761074Orig1s000TOC.cfm | url-status=live }} || trastuzumab-dkst/Ogivri || [[trastuzumab]]/Herceptin [138] => |- [139] => | December 2017{{cite web | title=Drug Approval Package: Ixifi (infliximab-qbtx) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=November 29, 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761072Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218044952/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761072Orig1s000TOC.cfm | url-status=live }} || infliximab-qbtx/Ixifi || [[infliximab]]/Remicade [140] => |- [141] => | May 2018{{cite press release|url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-epoetin-alfa-biosimilar-treatment-anemia|title=FDA approves first epoetin alfa biosimilar for the treatment of anemia|publisher=U.S. [[Food and Drug Administration]] (FDA)|access-date=December 17, 2020|archive-date=August 28, 2021|archive-url=https://web.archive.org/web/20210828202332/https://www.fda.gov/news-events/press-announcements/fda-approves-first-epoetin-alfa-biosimilar-treatment-anemia|url-status=live}}{{cite web | title=Drug Approval Package: Retacrit (epoetin alfa-epbx ) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=December 13, 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125545Orig1s000TOC.cfm | access-date=November 26, 2023 | archive-date=September 27, 2021 | archive-url=https://web.archive.org/web/20210927125923/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125545Orig1s000TOC.cfm | url-status=live }} || epoetin alfa-epbx/Retacrit || [[epoetin alfa]]/Procrit [142] => |- [143] => |June 2018{{cite press release |url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-neulasta-help-reduce-risk-infection-during-cancer-treatment |title=FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment |publisher=U.S. [[Food and Drug Administration]] (FDA) |access-date=December 17, 2020 |archive-date=June 11, 2020 |archive-url=https://web.archive.org/web/20200611202206/https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-neulasta-help-reduce-risk-infection-during-cancer-treatment |url-status=live }}{{cite web | title=Drug Approval Package: Fulphila | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=October 26, 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761075Orig1s000TOC.cfm | access-date=November 26, 2023 | archive-date=June 11, 2020 | archive-url=https://web.archive.org/web/20200611203416/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761075Orig1s000TOC.cfm | url-status=live }} || pegfilgrastim-jmdb/Fulphila || [[pegfilgrastim]]/Neulasta [144] => |- [145] => | July 2018{{cite web | title=Drug Approval Package: Nivestym (filgrastim-aafi) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=February 21, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761080Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 20, 2019 | archive-url=https://web.archive.org/web/20191220184614/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761080Orig1s000TOC.cfm | url-status=live }} || filgrastim-aafi/Nivestym || [[filgrastim]]/Neupogen [146] => |- [147] => | October 2018{{cite web | title=Drug Approval Package: Hyrimoz | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=March 21, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761071Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218044943/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761071Orig1s000TOC.cfm | url-status=live }} || adalimumab-adaz/Hyrimoz || [[adalimumab]]/Humira [148] => |- [149] => | November 2018{{cite web | title=Drug Approval Package: Udenyca | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=March 5, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761039Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218045004/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761039Orig1s000TOC.cfm | url-status=live }} || pegfilgrastim-cbqv/Udenyca || [[pegfilgrastim]]/Neulasta [150] => |- [151] => | November 2018{{cite web | title=Drug Approval Package: Truxima (rituximab-abbs) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=February 25, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761088Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218045017/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761088Orig1s000TOC.cfm | url-status=live }} || rituximab-abbs/Truxima || [[rituximab]]/Rituxan [152] => |- [153] => | December 2018{{cite web | title=Drug Approval Package: Herzuma | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=February 7, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761091Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218045010/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761091Orig1s000TOC.cfm | url-status=live }} || trastuzumab-pkrb/Herzuma || [[trastuzumab]]/Herceptin [154] => |- [155] => | January 2019{{cite web | title=Drug Approval Package: Ontruzant (trastuzumab-dttb) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=March 5, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761100Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218045033/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761100Orig1s000TOC.cfm | url-status=live }} || trastuzumab-dttb/Ontruzant || [[trastuzumab]]/Herceptin [156] => |- [157] => | March 2019{{cite web | title=Drug Approval Package: Trazimera (trastuzumab-qyyp) | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=May 17, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761081Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218044941/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761081Orig1s000TOC.cfm | url-status=live }} || trastuzumab-qyyp/Trazimera || [[trastuzumab]]/Herceptin [158] => |- [159] => | April 2019{{cite web | title=Drug Approval Package: Eticovo | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=June 18, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761066Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218044939/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761066Orig1s000TOC.cfm | url-status=live }} || etanercept-ykro/Eticovo || [[etanercept]]/Enbrel [160] => |- [161] => | June 2019{{cite web | title=Drug Approval Package: Kanjinti | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=July 18, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761073Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218044956/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761073Orig1s000TOC.cfm | url-status=live }} || trastuzumab-anns/Kanjinti || [[trastuzumab]]/Herceptin [162] => |- [163] => | June 2019{{cite web | title=Drug Approval Package: Zirabev | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=August 14, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761099Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218044943/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761099Orig1s000TOC.cfm | url-status=live }} || bevacizumab-bvzr/Zirabev || [[bevacizumab]]/Avastin [164] => |- [165] => | July 2019{{cite web | title=Drug Approval Package: Ruxience | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=August 9, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761103Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218044918/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761103Orig1s000TOC.cfm | url-status=live }} || rituximab-pvvr/Ruxience || [[rituximab]]/Rituxan [166] => |- [167] => | July 2019{{cite web | title=Drug Approval Package: Hadlima | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=September 5, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761059Orig1s000TOC.cfm | access-date=December 17, 2019 | archive-date=December 18, 2019 | archive-url=https://web.archive.org/web/20191218044930/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761059Orig1s000TOC.cfm | url-status=live }} || adalimumab-bwwd/Hadlima || [[adalimumab]]/Humira [168] => |- [169] => | November 2019{{cite web | title=Drug Approval Package: Ziextenzo | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=December 27, 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761045Orig1s000TOC.cfm | access-date=December 17, 2020 | archive-date=June 11, 2020 | archive-url=https://web.archive.org/web/20200611203414/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761045Orig1s000TOC.cfm | url-status=live }} || pegfilgrastim-bmez/Ziextenzo || [[pegfilgrastim]]/Neulasta [170] => |- [171] => | November 2019{{cite web | title=Drug Approval Package: Abrilada | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=January 28, 2020 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761118Orig1s000TOC.cfm | access-date=December 17, 2020 | archive-date=October 4, 2020 | archive-url=https://web.archive.org/web/20201004035524/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761118Orig1s000TOC.cfm | url-status=live }} || adalimumab-afzb/Abrilada || [[adalimumab]]/Humira [172] => |- [173] => | December 2019{{cite web | title=Drug Approval Package: Avsola | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=January 30, 2020 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761086Orig1s000TOC.cfm | access-date=December 17, 2020 | archive-date=November 1, 2020 | archive-url=https://web.archive.org/web/20201101090550/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761086Orig1s000TOC.cfm | url-status=live }} || infliximab-axxq/Avsola || [[infliximab]]/Remicade [174] => |- [175] => | June 2020{{cite web | title=Drug Approval Package: Nyvepria | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=August 11, 2020 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761111Orig1s000TOC.cfm | access-date=December 17, 2020 | archive-date=January 25, 2021 | archive-url=https://web.archive.org/web/20210125043237/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761111Orig1s000TOC.cfm | url-status=live }} || pegfilgrastim-apgf/Nyvepria || [[pegfilgrastim]]/Neulasta [176] => |- [177] => | July 2020{{cite web | title=Drug Approval Package: Hulio | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=October 2, 2020 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761154Orig1s000TOC.cfm | access-date=December 17, 2020 | archive-date=November 6, 2021 | archive-url=https://web.archive.org/web/20211106210639/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761154Orig1s000TOC.cfm | url-status=live }} || adalimumab-fkjp/Hulio || [[adalimumab]]/Humira [178] => |- [179] => | December 2020{{cite web | title=Drug Approval Package: Riabni | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=January 26, 2021 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761140Orig1s000TOC.cfm | access-date=August 28, 2021 | archive-date=August 28, 2021 | archive-url=https://web.archive.org/web/20210828185638/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761140Orig1s000TOC.cfm | url-status=live }} || rituximab-arrx/Riabni || [[rituximab]]/Rituxan [180] => |- [181] => | July 2021{{cite web | title=Drug Approval Package: Semglee | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=September 2, 2021 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761201Orig1s000TOC.cfm | access-date=May 26, 2022 | archive-date=May 27, 2022 | archive-url=https://web.archive.org/web/20220527031832/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761201Orig1s000TOC.cfm | url-status=live }} || insulin glargine-yfgn/Semglee || [[insulin glargine]]/Lantus [182] => |- [183] => | September 2021{{cite web | title=Drug Approval Package: Byooviz | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=October 1, 2021 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761202Orig1s000TOC.cfm | access-date=August 25, 2023 | archive-date=January 25, 2023 | archive-url=https://web.archive.org/web/20230125225422/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761202Orig1s000TOC.cfm | url-status=live }} || ranibizumab-nuna/Byooviz || [[ranibizumab]]/Lucentis [184] => |- [185] => | December 2021{{cite web | title=Drug Approval Package: Rezvoglar | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=January 28, 2022 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761215Orig1s000TOC.cfm | access-date=May 26, 2022 | archive-date=May 27, 2022 | archive-url=https://web.archive.org/web/20220527031831/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761215Orig1s000TOC.cfm | url-status=live }} || insulin glargine-aglr/Rezvoglar || [[insulin glargine]]/Lantus [186] => |- [187] => | December 2021{{cite web | title=Drug Approval Package: Yusimry | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=January 18, 2021 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761216Orig1s000TOC.cfm | access-date=May 26, 2022 | archive-date=May 27, 2022 | archive-url=https://web.archive.org/web/20220527031830/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761216Orig1s000TOC.cfm | url-status=live }} || adalimumab-aqvh/Yusimry || [[adalimumab]]/Humira [188] => |- [189] => | February 2022{{cite web | title=Drug Approval Package: Releuko | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=April 11, 2022 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761082Orig1s000TOC.cfm | access-date=May 26, 2022 | archive-date=May 27, 2022 | archive-url=https://web.archive.org/web/20220527031831/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761082Orig1s000TOC.cfm | url-status=live }} || filgrastim-ayow/Releuko || [[filgrastim]]/Neupogen [190] => |- [191] => | April 2022{{cite web | title=Drug Approval Package: Alymsys | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=May 11, 2022 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761231Orig1s000TOC.cfm | access-date=May 27, 2022 | archive-date=May 27, 2022 | archive-url=https://web.archive.org/web/20220527031831/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761231Orig1s000TOC.cfm | url-status=live }} || bevacizumab-maly/Alymsys || [[bevacizumab]]/Avastin [192] => |- [193] => | May 2022{{cite web | title=Drug Approval Package: Fylnetra | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=July 15, 2022 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761084Orig1s000TOC.cfm | access-date=August 25, 2023 | archive-date=September 3, 2022 | archive-url=https://web.archive.org/web/20220903040614/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761084Orig1s000TOC.cfm | url-status=live }} || pegfilgrastim-pbbk/Fylnetra || [[pegfilgrastim]]/Neulasta [194] => |- [195] => | August 2022{{cite web | title=Drug Approval Package: Cimerli | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=August 23, 2022 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761165Orig1s000TOC.cfm | access-date=September 28, 2022 | archive-date=September 29, 2022 | archive-url=https://web.archive.org/web/20220929025550/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761165Orig1s000TOC.cfm | url-status=live }} || ranibizumab-eqrn/Cimerli || [[ranibizumab]]/Lucentis [196] => |- [197] => | September 2022{{cite web | title=Drug Approval Package: Stimufend | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=November 16, 2022 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761173Orig1s000TOC.cfm | access-date=August 25, 2023 | archive-date=January 26, 2023 | archive-url=https://web.archive.org/web/20230126010814/http://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761173Orig1s000TOC.cfm | url-status=live }} || pegfilgrastim-fpgk/Stimufend || [[pegfilgrastim]]/Neulasta [198] => |- [199] => | September 2022{{cite web | title=Drug Approval Package: Vegzelma | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=December 13, 2022 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761268Orig1s000TOC.cfm | access-date=August 25, 2023 | archive-date=August 25, 2023 | archive-url=https://web.archive.org/web/20230825224035/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761268Orig1s000TOC.cfm | url-status=live }} || bevacizumab-adcd/Vegzelma || [[bevacizumab]]/Avastin [200] => |- [201] => | December 2022{{cite web | title=Drug Approval Package: Idacio | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=February 9, 2023 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761255Orig1s000TOC.cfm | access-date=August 25, 2023 | archive-date=February 10, 2023 | archive-url=https://web.archive.org/web/20230210001159/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761255Orig1s000TOC.cfm | url-status=live }} || adalimumab-aacf/Idacio || [[adalimumab]]/Humira [202] => |- [203] => | May 2023{{cite web | title=Drug Approval Package: Yuflyma injection | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=August 11, 2023 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761219Orig1s000TOC.cfm | access-date=August 25, 2023 | archive-date=August 25, 2023 | archive-url=https://web.archive.org/web/20230825223940/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761219Orig1s000TOC.cfm | url-status=live }} || adalimumab-aaty/Yuflyma || [[adalimumab]]/Humira [204] => |- [205] => | August 2023{{cite web | title=Drug Approval Package: Tyruko | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=October 11, 2023 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761322Orig1s000TOC.cfm | access-date=November 26, 2023 | archive-date=November 26, 2023 | archive-url=https://web.archive.org/web/20231126190153/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761322Orig1s000TOC.cfm | url-status=live }} || natalizumab-sztn/Tyruko || [[natalizumab]]/Tysabri [206] => |- [207] => | September 2023{{cite web | title=Drug Approval Package: Tofidence | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=November 7, 2023 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761354Orig1s000TOC.cfm | access-date=November 26, 2023}} || tocilizumab-bavi/Tofidence || [[tocilizumab]]/Actemra [208] => |- [209] => | October 2023{{cite press release | title=FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=October 31, 2023 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases | access-date=November 13, 2023 | archive-date=November 13, 2023 | archive-url=https://web.archive.org/web/20231113104806/https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases | url-status=live }} || ustekinumab-auub/Wezlana || [[ustekinumab]]/Stelara [210] => |- [211] => | December 2023 || bevacizumab-tnjn/Avzivi || [[bevacizumab]]/Avastin [212] => |- [213] => | February 2024 || adalimumab-ryvk/Simlandi || [[adalimumab]]/Humira [214] => |- [215] => | March 2024 || denosumab-bbdz/Jubbonti || [[denosumab]]/Prolia [216] => |- [217] => | March 2024 || denosumab-bbdz/Wyost || [[denosumab]]/Xgeva [218] => |} [219] => [220] => == References == [221] => {{Reflist}} [222] => [223] => == Further reading == [224] => * {{cite journal | vauthors = Udpa N, Million RP | title = Monoclonal antibody biosimilars | journal = Nature Reviews. Drug Discovery | volume = 15 | issue = 1 | pages = 13–4 | date = January 2016 | pmid = 26678619 | doi = 10.1038/nrd.2015.12 | s2cid = 27954836 }} [225] => * {{cite journal | vauthors = Jelkmann W | title = Biosimilar epoetins and other "follow-on" biologics: update on the European experiences | journal = American Journal of Hematology | volume = 85 | issue = 10 | pages = 771–80 | date = October 2010 | pmid = 20706990 | doi = 10.1002/ajh.21805 | s2cid = 205293428 | url = https://hal.archives-ouvertes.fr/hal-00552331/document | doi-access = free }} [226] => [227] => == External links == [228] => * [https://www.fda.gov/media/151058/download Overview of Biosimilar Products] U.S. [[Food and Drug Administration]] [229] => * [https://www.fda.gov/media/151061/download Biosimilar Regulatory Review and Approval ] U.S. [[Food and Drug Administration]] [230] => * [https://www.fda.gov/media/151094/download Interchangeable Biological Products ] U.S. [[Food and Drug Administration]] [231] => [232] => {{Portal bar | Medicine}} [233] => {{Authority control}} [234] => [235] => [[Category:Biopharmaceuticals]] [236] => [[Category:Life sciences industry]] [] => )
good wiki

Biosimilar

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires.

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