Biosimilar Explained

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.[1] Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.[2]

Unlike with generic drugs of the more common small-molecule type, biologics generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite that heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle.[3]

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.

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.[4] [5] [6] [7]

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.[8] 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.

Approval processes

United States

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.[9] Additional Congressional hearings have been held.[10] On March 17, 2009, the Pathway for Biosimilars Act was introduced in the House.[11] Since 2004 the FDA has held a series of public meetings on biosimilars.[12] [13]

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.

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 under the FD&C Act.[14]

On March 6, 2015, Zarxio obtained the first approval of FDA.[15] 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.

In March 2020, most protein products that were approved as drug products (including every insulin currently on the market) are scheduled to open up to biosimilar and interchangeable competition in the United States.[16] 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.

Background

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- and cell-based therapies are emerging as new approaches.

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.

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 biologics (thus called biosimilars).

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.

The current concept of development of biosimilar monoclonal antibodies 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 monoclonal antibody also at the clinical level.

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.[17]

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.[18] 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.[19] [20]

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.

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.

Nomenclature

In the European Union, no unique identifier of a biosimilar medicine product is required, as the same rules are followed as for all biologics.

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.[21] Japan has similar requirements.[22] The suffix approach has been criticized on the grounds of compromising the INN system and delaying the marketing of biosimilars.[22] Australia decided not to use a 4-letter suffix.[23] [24] [25]

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.[26] 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."[27]

Australia

Biosimilars available in Australia include adalimumab, bevacizumab, enoxaparin, epoetin lambda, etanercept, filgrastim, follitropin alfa, infliximab, insulin aspart, insulin glargine, pegfilgrastim, rituximab, teriparatide, and trastuzumab.[28]

Egypt

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.[29]

Key Findings and Recommendations of the article
  1. 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.
  2. Reimbursement: A significant emphasis was placed on using 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.
  3. 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.
  4. 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.

European Union

Biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.[30]

European Union approved biosimilars[31]
Active substance Reference product Biosimilar medicines
Humira[32] Amgevita,[33] Amsparity,[34] Cyltezo,[35] Halimatoz,[36] Hefiya,[37] Hukyndra,[38] Hulio,[39] Hyrimoz,[40] Idacio,[41] Imraldi,[42] Kromeya,[43] Libmyris,[44] Solymbic,[45] Trudexa,[46] Yuflyma[47]
Avastin[48] Abevmy,[49] Alymsys,[50] Aybintio,[51] Equidacent,[52] Mvasi,[53] Onbevzi,[54] Oyavas,[55] Vegzelma,[56] Zirabev[57]
Clexane Inhixa,[58] Thorinane[59]
Eprex/Erypo Abseamed,[60] Binocrit,[61] Epoetin Alfa Hexal,[62] Retacrit,[63] Silapo[64]
Enbrel[65] Benepali,[66] Erelzi,[67] Lifmior,[68] Nepexto[69]
Neupogen Accofil,[70] Biograstim,[71] Filgrastim Hexal,[72] Filgrastim ratiopharm,[73] Grastofil,[74] Nivestim,[75] Ratiograstim,[76] Tevagrastim,[77] Zarzio[78]
Gonal-F[79] Bemfola,[80] Ovaleap[81]
Remicade[82] Flixabi,[83] Inflectra,[84] Remsima,[85] Zessly[86]
NovoRapid[87] Fiasp,[88] Insulin aspart Sanofi,[89] Kirsty,[90] NovoMix,[91] Ryzodeg[92]
Lantus[93] Abasaglar,[94] Semglee[95]
Humalog[96] Insulin lispro Sanofi[97]
Neulasta[98] Cegfila,[99] Fulphila,[100] Grasustek,[101] Pelgraz,[102] Pelmeg,[103] Udenyca,[104] Stimufend,[105] Ziextenzo[106]
Lucentis[107] Byooviz,[108] Ranivisio,[109] Ximluci[110]
MabThera[111] Blitzima,[112] Ritemvia,[113] Rituzena,[114] Rixathon,[115] Riximyo,[116] Ruxience,[117] Truxima[118]
Genotropin Omnitrope[119]
Forsteo[120] Movymia,[121] Terrosa[122]
RoActemra[123] Tyenne[124]
Herceptin[125] Herzuma,[126] Kanjinti,[127] Ogivri,[128] Ontruzant,[129] Trazimera,[130] Zercepac[131]

United States

BPCI Act

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was originally sponsored and introduced on June 26, 2007, by Senator 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.[132] 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.[133]

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.[134]

US approved biosimilars

Date of Biosimilar FDA Approval Biosimilar Product[135] Original Product
March 2015[136] filgrastim-sndz/Zarxio filgrastim/Neupogen
April 2016[137] infliximab-dyyb/Inflectra infliximab/Remicade
August 2016[138] [139] etanercept-szzs/Erelzi etanercept/Enbrel
September 2016[140] [141] adalimumab-atto/Amjevita adalimumab/Humira
April 2017[142] infliximab-abda/Renflexis infliximab/Remicade
August 2017[143] adalimumab-adbm/Cyltezo adalimumab/Humira
September 2017[144] [145] bevacizumab-awwb/Mvasi bevacizumab/Avastin
December 2017[146] [147] trastuzumab-dkst/Ogivri trastuzumab/Herceptin
December 2017[148] infliximab-qbtx/Ixifi infliximab/Remicade
May 2018[149] [150] epoetin alfa-epbx/Retacrit epoetin alfa/Procrit
June 2018[151] [152] pegfilgrastim-jmdb/Fulphila pegfilgrastim/Neulasta
July 2018[153] filgrastim-aafi/Nivestym filgrastim/Neupogen
October 2018[154] adalimumab-adaz/Hyrimoz adalimumab/Humira
November 2018[155] pegfilgrastim-cbqv/Udenyca pegfilgrastim/Neulasta
November 2018[156] rituximab-abbs/Truxima rituximab/Rituxan
December 2018[157] trastuzumab-pkrb/Herzuma trastuzumab/Herceptin
January 2019[158] trastuzumab-dttb/Ontruzant trastuzumab/Herceptin
March 2019[159] trastuzumab-qyyp/Trazimera trastuzumab/Herceptin
April 2019[160] etanercept-ykro/Eticovo etanercept/Enbrel
June 2019[161] trastuzumab-anns/Kanjinti trastuzumab/Herceptin
June 2019[162] bevacizumab-bvzr/Zirabev bevacizumab/Avastin
July 2019[163] rituximab-pvvr/Ruxience rituximab/Rituxan
July 2019[164] adalimumab-bwwd/Hadlima adalimumab/Humira
November 2019[165] pegfilgrastim-bmez/Ziextenzo pegfilgrastim/Neulasta
November 2019[166] adalimumab-afzb/Abrilada adalimumab/Humira
December 2019[167] infliximab-axxq/Avsola infliximab/Remicade
June 2020[168] pegfilgrastim-apgf/Nyvepria pegfilgrastim/Neulasta
July 2020[169] adalimumab-fkjp/Hulio adalimumab/Humira
December 2020[170] rituximab-arrx/Riabni rituximab/Rituxan
July 2021[171] insulin glargine-yfgn/Semglee insulin glargine/Lantus
September 2021[172] ranibizumab-nuna/Byooviz ranibizumab/Lucentis
December 2021[173] insulin glargine-aglr/Rezvoglar insulin glargine/Lantus
December 2021[174] adalimumab-aqvh/Yusimry adalimumab/Humira
February 2022[175] filgrastim-ayow/Releuko filgrastim/Neupogen
April 2022[176] bevacizumab-maly/Alymsys bevacizumab/Avastin
May 2022[177] pegfilgrastim-pbbk/Fylnetra pegfilgrastim/Neulasta
August 2022[178] ranibizumab-eqrn/Cimerli ranibizumab/Lucentis
September 2022[179] pegfilgrastim-fpgk/Stimufend pegfilgrastim/Neulasta
September 2022[180] bevacizumab-adcd/Vegzelma bevacizumab/Avastin
December 2022[181] adalimumab-aacf/Idacio adalimumab/Humira
May 2023[182] adalimumab-aaty/Yuflyma adalimumab/Humira
August 2023[183] natalizumab-sztn/Tyruko natalizumab/Tysabri
September 2023[184] tocilizumab-bavi/Tofidence tocilizumab/Actemra
October 2023[185] ustekinumab-auub/Wezlana ustekinumab/Stelara
December 2023 bevacizumab-tnjn/Avzivi bevacizumab/Avastin
February 2024 adalimumab-ryvk/Simlandi adalimumab/Humira
March 2024 denosumab-bbdz/Jubbonti denosumab/Prolia
March 2024 denosumab-bbdz/Wyost denosumab/Xgeva

Further reading

External links

Notes and References

  1. 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
  2. Web site: Biosimilars in the EU: Information guide for healthcare professionals . European Medicines Agency and the European Commission . 2017 . https://web.archive.org/web/20191015204916/https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf . October 15, 2019.
  3. Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, Seidl A, Schiestl M . Maintaining consistent quality and clinical performance of biopharmaceuticals . Expert Opinion on Biological Therapy . 18 . 4 . 369–379 . April 2018 . 29285958 . 10.1080/14712598.2018.1421169 . free .
  4. Guidelines on evaluation of similar Biotherapeutic Products (SBPs). 2009. World Health Organization (WHO). October 24, 2019. September 29, 2021. https://web.archive.org/web/20210929201936/https://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. dead.
  5. Guidelines on evaluation of similar Biotherapeutic Products (SBPs), Annex 2, Technical Report Series No. 977 . World Health Organization (WHO) . 2013 . December 18, 2019 . May 30, 2015 . https://web.archive.org/web/20150530015521/http://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf?ua=1 . live .
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  10. 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
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  13. Web site: FDA page on "Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting". https://web.archive.org/web/20101007165215/http://www.fda.gov/Drugs/NewsEvents/ucm221688.htm. dead. October 7, 2010. U.S. Food and Drug Administration (FDA).
  14. Web site: FDA Response to three Citizen Petitions against biosimilars. U.S. Food and Drug Administration (FDA). December 16, 2019. May 31, 2017. https://web.archive.org/web/20170531010155/https://www.fda.gov/ohrms/dockets/dockets/04p0231/04p-0231-pdn0001.pdf. live.
  15. Web site: FDA page on "FDA approves first biosimilar product Zarxio". https://web.archive.org/web/20150307142645/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm. dead. March 7, 2015. U.S. Food and Drug Administration (FDA).
  16. Web site: Statement on low-cost biosimilar and interchangeable protein products . U.S. Food and Drug Administration (FDA) . December 17, 2019 . https://web.archive.org/web/20191218020741/https://www.fda.gov/news-events/press-announcements/statement-low-cost-biosimilar-and-interchangeable-protein-products . December 18, 2019 . live . December 17, 2019.
  17. http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf EMEA guideline on similar biological medicinal products
  18. Warren JB . Generics, chemisimilars and biosimilars: is clinical testing fit for purpose? . British Journal of Clinical Pharmacology . 75 . 1 . 7–14 . January 2013 . 22574725 . 3555041 . 10.1111/j.1365-2125.2012.04323.x .
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  35. Web site: Cyltezo EPAR . European Medicines Agency (EMA) . August 27, 2021 . August 6, 2020 . https://web.archive.org/web/20200806180247/https://www.ema.europa.eu/en/medicines/human/EPAR/cyltezo . live .
  36. Web site: Halimatoz EPAR . European Medicines Agency (EMA) . April 21, 2020 . December 30, 2019 . https://web.archive.org/web/20191230161739/https://www.ema.europa.eu/en/medicines/human/EPAR/halimatoz . live .
  37. Web site: Hefiya EPAR . European Medicines Agency (EMA) . April 21, 2020 . October 15, 2019 . https://web.archive.org/web/20191015195616/https://www.ema.europa.eu/en/medicines/human/EPAR/hefiya . live .
  38. Web site: Hukyndra EPAR . European Medicines Agency (EMA) . September 14, 2021 . April 23, 2022 . April 24, 2022 . https://web.archive.org/web/20220424041728/https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra . live .
  39. Web site: Hulio EPAR . European Medicines Agency (EMA) . April 21, 2020 . March 24, 2020 . https://web.archive.org/web/20200324055630/https://www.ema.europa.eu/en/medicines/human/EPAR/hulio . live .
  40. Web site: Hyrimoz EPAR . European Medicines Agency (EMA) . April 21, 2020 . November 16, 2019 . https://web.archive.org/web/20191116205930/https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz . live .
  41. Web site: Idacio EPAR . European Medicines Agency (EMA) . January 29, 2019 . April 21, 2020 . December 30, 2019 . https://web.archive.org/web/20191230161513/https://www.ema.europa.eu/en/medicines/human/EPAR/idacio . live .
  42. Web site: Imraldi EPAR . European Medicines Agency (EMA) . April 21, 2020 . March 24, 2020 . https://web.archive.org/web/20200324045318/https://www.ema.europa.eu/en/medicines/human/EPAR/imraldi . live .
  43. Web site: Kromeya EPAR . European Medicines Agency (EMA) . January 29, 2019 . August 27, 2021 . December 30, 2019 . https://web.archive.org/web/20191230161654/https://www.ema.europa.eu/en/medicines/human/EPAR/kromeya . live .
  44. Web site: Libmyris EPAR . European Medicines Agency (EMA) . September 14, 2021 . April 23, 2022 . April 24, 2022 . https://web.archive.org/web/20220424041731/https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris . live .
  45. Web site: Solymbic EPAR . European Medicines Agency (EMA) . August 27, 2021 . June 25, 2019 . https://web.archive.org/web/20190625133941/https://www.ema.europa.eu/en/medicines/human/EPAR/solymbic . live .
  46. Web site: Trudexa EPAR . European Medicines Agency (EMA) . August 27, 2021 . February 18, 2020 . https://web.archive.org/web/20200218190523/https://www.ema.europa.eu/en/medicines/human/EPAR/trudexa . live .
  47. Web site: Yuflyma EPAR . European Medicines Agency (EMA) . December 9, 2020 . August 27, 2021 . August 28, 2021 . https://web.archive.org/web/20210828065111/https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma . live .
  48. Web site: Avastin EPAR . European Medicines Agency (EMA) . September 11, 2021 . March 18, 2020 . https://web.archive.org/web/20200318210110/https://www.ema.europa.eu/en/medicines/human/EPAR/avastin . live .
  49. Web site: Abevmy EPAR . European Medicines Agency (EMA) . February 24, 2021 . August 27, 2021 . August 28, 2021 . https://web.archive.org/web/20210828061650/https://www.ema.europa.eu/en/medicines/human/EPAR/abevmy . live .
  50. Web site: Alymsys EPAR . European Medicines Agency (EMA) . January 25, 2021 . September 11, 2021 . October 8, 2021 . https://web.archive.org/web/20211008120839/https://www.ema.europa.eu/en/medicines/human/EPAR/alymsys . live .
  51. Web site: Aybintio EPAR . European Medicines Agency (EMA) . May 26, 2020 . September 9, 2020 . December 29, 2020 . https://web.archive.org/web/20201229221338/https://www.ema.europa.eu/en/medicines/human/EPAR/aybintio . live .
  52. Web site: Equidacent EPAR . European Medicines Agency (EMA) . July 20, 2020 . October 12, 2020 . October 13, 2020 . https://web.archive.org/web/20201013000306/https://www.ema.europa.eu/en/medicines/human/EPAR/equidacent . live .
  53. Web site: Mvasi EPAR . European Medicines Agency (EMA) . April 2, 2020 . December 30, 2019 . https://web.archive.org/web/20191230161123/https://www.ema.europa.eu/en/medicines/human/EPAR/mvasi . live .
  54. Web site: Onbevzi EPAR . European Medicines Agency (EMA) . November 9, 2020 . September 11, 2021 . November 5, 2021 . https://web.archive.org/web/20211105130152/https://www.ema.europa.eu/en/medicines/human/EPAR/onbevzi . live .
  55. Web site: Oyavas EPAR . European Medicines Agency (EMA) . January 25, 2021 . September 11, 2021 . October 8, 2021 . https://web.archive.org/web/20211008175537/https://www.ema.europa.eu/en/medicines/human/EPAR/oyavas . live .
  56. Web site: Vegzelma EPAR . European Medicines Agency (EMA) . June 20, 2022 . March 3, 2023 . January 28, 2023 . https://web.archive.org/web/20230128020239/https://www.ema.europa.eu/en/medicines/human/EPAR/vegzelma . live .
  57. Web site: Zirabev EPAR . European Medicines Agency (EMA) . December 11, 2018 . April 2, 2020 . December 30, 2019 . https://web.archive.org/web/20191230160954/https://www.ema.europa.eu/en/medicines/human/EPAR/zirabev . live .
  58. Web site: Inhixa EPAR . European Medicines Agency (EMA) . September 9, 2020 . October 29, 2020 . https://web.archive.org/web/20201029200312/https://www.ema.europa.eu/en/medicines/human/EPAR/inhixa . live .
  59. Web site: Thorinane EPAR . European Medicines Agency (EMA) . April 2, 2020 . December 30, 2019 . https://web.archive.org/web/20191230161610/https://www.ema.europa.eu/en/medicines/human/EPAR/thorinane . live .
  60. Web site: Abseamed EPAR . European Medicines Agency (EMA) . April 4, 2022 . March 23, 2020 . https://web.archive.org/web/20200323234939/https://www.ema.europa.eu/en/medicines/human/EPAR/abseamed . live .
  61. Web site: Binocrit EPAR . European Medicines Agency (EMA) . April 4, 2022 . December 30, 2019 . https://web.archive.org/web/20191230161254/https://www.ema.europa.eu/en/medicines/human/EPAR/binocrit . live .
  62. Web site: Epoetin Alfa Hexal EPAR . European Medicines Agency (EMA) . April 4, 2022 . December 30, 2019 . https://web.archive.org/web/20191230162049/https://www.ema.europa.eu/en/medicines/human/EPAR/epoetin-alfa-hexal . live .
  63. Web site: Retacrit EPAR . European Medicines Agency (EMA) . April 4, 2022 . December 30, 2019 . https://web.archive.org/web/20191230161825/https://www.ema.europa.eu/en/medicines/human/EPAR/retacrit . live .
  64. Web site: Silapo EPAR . European Medicines Agency (EMA) . April 4, 2022 . October 22, 2020 . https://web.archive.org/web/20201022043818/https://www.ema.europa.eu/en/medicines/human/EPAR/silapo . live .
  65. Web site: Enbrel EPAR . European Medicines Agency (EMA) . March 7, 2024 . November 12, 2020 . https://web.archive.org/web/20201112014334/https://www.ema.europa.eu/en/medicines/human/EPAR/enbrel . live .
  66. Web site: Benepali EPAR . European Medicines Agency (EMA) . April 4, 2022 . December 30, 2019 . https://web.archive.org/web/20191230160905/https://www.ema.europa.eu/en/medicines/human/EPAR/benepali . live .
  67. Web site: Erelzi EPAR . European Medicines Agency (EMA) . April 4, 2022 . December 30, 2019 . https://web.archive.org/web/20191230160647/https://www.ema.europa.eu/en/medicines/human/EPAR/erelzi . live .
  68. Web site: Lifmior EPAR . European Medicines Agency (EMA) . April 2, 2020.
  69. Web site: Nepexto EPAR . European Medicines Agency (EMA) . March 24, 2020 . June 4, 2020 . June 4, 2020 . https://web.archive.org/web/20200604183709/https://www.ema.europa.eu/en/medicines/human/EPAR/nepexto . live .
  70. Web site: Accofil EPAR . European Medicines Agency (EMA) . April 4, 2022 . March 23, 2020 . https://web.archive.org/web/20200323235656/https://www.ema.europa.eu/en/medicines/human/EPAR/accofil . live .
  71. Web site: Biograstim EPAR . European Medicines Agency (EMA) . September 17, 2018 . April 2, 2020 . October 22, 2020 . https://web.archive.org/web/20201022204309/https://www.ema.europa.eu/en/medicines/human/EPAR/biograstim . live .
  72. Web site: Filgrastim Hexal EPAR . European Medicines Agency (EMA) . April 4, 2022 . December 30, 2019 . https://web.archive.org/web/20191230161956/https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-hexal . live .
  73. Web site: Filgrastim ratiopharm EPAR . European Medicines Agency (EMA) . September 17, 2018 . April 2, 2020 . January 21, 2021 . https://web.archive.org/web/20210121002356/https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-ratiopharm . live .
  74. Web site: Grastofil EPAR . European Medicines Agency (EMA) . April 4, 2022 . November 12, 2020 . https://web.archive.org/web/20201112002249/https://www.ema.europa.eu/en/medicines/human/EPAR/grastofil . live .
  75. Web site: Nivestim EPAR . European Medicines Agency (EMA) . April 4, 2022 . December 20, 2019 . https://web.archive.org/web/20191220191624/https://www.ema.europa.eu/en/medicines/human/EPAR/nivestim . live .
  76. Web site: Ratiograstim EPAR . European Medicines Agency (EMA) . April 4, 2022 . August 14, 2020 . https://web.archive.org/web/20200814211722/https://www.ema.europa.eu/en/medicines/human/EPAR/ratiograstim . live .
  77. Web site: Tevagrastim EPAR . European Medicines Agency (EMA) . April 4, 2022 . October 16, 2019 . https://web.archive.org/web/20191016120016/https://www.ema.europa.eu/en/medicines/human/EPAR/tevagrastim . live .
  78. Web site: Zarzio EPAR . European Medicines Agency (EMA) . April 4, 2022 . October 15, 2019 . https://web.archive.org/web/20191015190413/https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio . live .
  79. Web site: Gonal-f EPAR . European Medicines Agency (EMA) . October 20, 1995 . March 7, 2024 . July 1, 2020 . https://web.archive.org/web/20200701090155/https://www.ema.europa.eu/en/medicines/human/EPAR/gonal-f . live .
  80. Web site: Bemfola EPAR . European Medicines Agency (EMA) . September 9, 2020 . October 28, 2020 . https://web.archive.org/web/20201028131041/https://www.ema.europa.eu/en/medicines/human/EPAR/bemfola . live .
  81. Web site: Ovaleap EPAR . European Medicines Agency (EMA) . September 9, 2020 . September 23, 2020 . https://web.archive.org/web/20200923142241/https://www.ema.europa.eu/en/medicines/human/EPAR/ovaleap . live .
  82. Web site: Remicade EPAR . European Medicines Agency (EMA) . March 7, 2024 . October 22, 2020 . https://web.archive.org/web/20201022094956/https://www.ema.europa.eu/en/medicines/human/EPAR/remicade . live .
  83. Web site: Flixabi EPAR . European Medicines Agency (EMA) . April 4, 2022 . October 16, 2019 . https://web.archive.org/web/20191016120357/https://www.ema.europa.eu/en/medicines/human/EPAR/flixabi . live .
  84. Web site: Inflectra EPAR . European Medicines Agency (EMA) . April 4, 2022 . October 16, 2019 . https://web.archive.org/web/20191016115847/https://www.ema.europa.eu/en/medicines/human/EPAR/inflectra . live .
  85. Web site: Remsima EPAR . European Medicines Agency (EMA) . April 4, 2022 . December 29, 2019 . https://web.archive.org/web/20191229225040/https://www.ema.europa.eu/en/medicines/human/EPAR/remsima . live .
  86. Web site: Zessly EPAR . European Medicines Agency (EMA) . April 4, 2022 . December 30, 2019 . https://web.archive.org/web/20191230161426/https://www.ema.europa.eu/en/medicines/human/EPAR/zessly . live .
  87. Web site: NovoRapid EPAR . European Medicines Agency (EMA) . March 7, 2024 . September 22, 2023 . https://web.archive.org/web/20230922163612/https://www.ema.europa.eu/en/medicines/human/EPAR/novorapid . live .
  88. Web site: Fiasp EPAR . European Medicines Agency (EMA) . August 27, 2021 . August 28, 2021 . https://web.archive.org/web/20210828065214/https://www.ema.europa.eu/en/medicines/human/EPAR/fiasp . live .
  89. Web site: Insulin aspart Sanofi EPAR . European Medicines Agency (EMA) . April 28, 2020 . September 9, 2020 . July 17, 2020 . https://web.archive.org/web/20200717193355/https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-aspart-sanofi . live .
  90. Web site: Kirsty EPAR . European Medicines Agency (EMA) . December 9, 2020 . September 14, 2021 . September 15, 2021 . https://web.archive.org/web/20210915064025/https://www.ema.europa.eu/en/medicines/human/EPAR/kirsty-previously-kixelle . live .
  91. Web site: NovoMix EPAR . European Medicines Agency (EMA) . August 27, 2021 . April 13, 2020 . https://web.archive.org/web/20200413050741/https://www.ema.europa.eu/en/medicines/human/EPAR/novomix . live .
  92. Web site: Ryzodeg EPAR . European Medicines Agency (EMA) . August 27, 2021 . August 28, 2021 . https://web.archive.org/web/20210828065133/https://www.ema.europa.eu/en/medicines/human/EPAR/ryzodeg . live .
  93. Web site: Lantus EPAR . European Medicines Agency (EMA) . March 7, 2024 . August 4, 2020 . https://web.archive.org/web/20200804155233/https://www.ema.europa.eu/en/medicines/human/EPAR/lantus . live .
  94. Web site: Abasaglar EPAR . European Medicines Agency (EMA) . April 4, 2022 . April 2, 2022 . https://web.archive.org/web/20220402171234/https://www.ema.europa.eu/en/medicines/human/EPAR/abasaglar-previously-abasria . live .
  95. Web site: Semglee EPAR . European Medicines Agency (EMA) . April 4, 2022 . February 15, 2022 . https://web.archive.org/web/20220215172501/https://www.ema.europa.eu/en/medicines/human/EPAR/semglee . live .
  96. Web site: Humalog EPAR . European Medicines Agency (EMA) . March 7, 2024 . February 24, 2020 . https://web.archive.org/web/20200224062204/https://www.ema.europa.eu/en/medicines/human/EPAR/humalog . live .
  97. Web site: Insulin lispro Sanofi EPAR . European Medicines Agency (EMA) . September 9, 2020 . February 24, 2020 . https://web.archive.org/web/20200224062115/https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-lispro-sanofi . live .
  98. Web site: Neulasta EPAR . European Medicines Agency (EMA) . April 2, 2020 . June 11, 2020 . https://web.archive.org/web/20200611210847/https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta . live .
  99. Web site: Cegfila (previously Pegfilgrastim Mundipharma) EPAR . European Medicines Agency (EMA) . October 16, 2019 . April 2, 2020 . June 11, 2020 . https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/cegfila . live .
  100. Web site: Fulphila EPAR . European Medicines Agency (EMA) . September 24, 2018 . April 2, 2020 . June 11, 2020 . https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila-0 . live .
  101. Web site: Grasustek EPAR . European Medicines Agency (EMA) . April 24, 2019 . April 2, 2020 . June 11, 2020 . https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek . live .
  102. Web site: Pelgraz EPAR . European Medicines Agency (EMA) . April 2, 2020 . December 30, 2019 . https://web.archive.org/web/20191230160459/https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz . live .
  103. Web site: Pelmeg EPAR . European Medicines Agency (EMA) . September 24, 2018 . April 2, 2020 . June 11, 2020 . https://web.archive.org/web/20200611210918/https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg . live .
  104. Web site: Udenyca . European Medicines Agency (EMA . April 2, 2020 . June 11, 2020 . https://web.archive.org/web/20200611210836/https://www.ema.europa.eu/en/medicines/human/EPAR/udenyca . live .
  105. Web site: Stimufend EPAR . European Medicines Agency (EMA) . January 24, 2022 . April 4, 2022 . April 21, 2022 . https://web.archive.org/web/20220421083742/https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend . live .
  106. Web site: Ziextenzo EPAR . European Medicines Agency (EMA) . September 24, 2018 . April 2, 2020 . June 11, 2020 . https://web.archive.org/web/20200611223851/https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo . live .
  107. Web site: Lucentis EPAR . European Medicines Agency (EMA) . September 9, 2021 . September 10, 2021 . https://web.archive.org/web/20210910053245/https://www.ema.europa.eu/en/medicines/human/EPAR/lucentis . live .
  108. Web site: Byooviz EPAR . European Medicines Agency (EMA) . June 23, 2021 . September 9, 2021 . September 10, 2021 . https://web.archive.org/web/20210910053259/https://www.ema.europa.eu/en/medicines/human/EPAR/byooviz . live .
  109. Web site: Ranivisio EPAR . European Medicines Agency (EMA) . June 20, 2022 . October 6, 2022 . October 6, 2022 . https://web.archive.org/web/20221006034343/https://www.ema.europa.eu/en/medicines/human/EPAR/ranivisio . live .
  110. Web site: Ximluci EPAR . European Medicines Agency (EMA) . September 14, 2022 . March 3, 2023 . March 13, 2023 . https://web.archive.org/web/20230313235137/https://www.ema.europa.eu/en/medicines/human/EPAR/ximluci . live .
  111. Web site: MabThera EPAR . European Medicines Agency (EMA) . September 8, 2021 . September 9, 2021 . https://web.archive.org/web/20210909063437/https://www.ema.europa.eu/en/medicines/human/EPAR/mabthera . live .
  112. Web site: Blitzima EPAR . European Medicines Agency (EMA) . September 8, 2021 . September 9, 2021 . https://web.archive.org/web/20210909064129/https://www.ema.europa.eu/en/medicines/human/EPAR/blitzima . live .
  113. Web site: Ritemvia EPAR . European Medicines Agency (EMA) . September 8, 2021 . September 9, 2021 . https://web.archive.org/web/20210909064151/https://www.ema.europa.eu/en/medicines/human/EPAR/ritemvia . live .
  114. Web site: Rituzena EPAR . European Medicines Agency (EMA) . September 8, 2021 . September 9, 2021 . https://web.archive.org/web/20210909064141/https://www.ema.europa.eu/en/medicines/human/EPAR/rituzena-previously-tuxella . live .
  115. Web site: Rixathon EPAR . European Medicines Agency (EMA) . September 8, 2021 . September 9, 2021 . https://web.archive.org/web/20210909064148/https://www.ema.europa.eu/en/medicines/human/EPAR/rixathon . live .
  116. Web site: Riximyo EPAR . European Medicines Agency (EMA) . September 8, 2021 . September 9, 2021 . https://web.archive.org/web/20210909064129/https://www.ema.europa.eu/en/medicines/human/EPAR/riximyo . live .
  117. Web site: Ruxience EPAR . European Medicines Agency (EMA) . January 29, 2020 . September 8, 2021 . September 9, 2021 . https://web.archive.org/web/20210909064140/https://www.ema.europa.eu/en/medicines/human/EPAR/ruxience . live .
  118. Web site: Truxima EPAR . European Medicines Agency (EMA) . September 8, 2021 . September 9, 2021 . https://web.archive.org/web/20210909064137/https://www.ema.europa.eu/en/medicines/human/EPAR/truxima . live .
  119. Web site: Omnitrope EPAR . European Medicines Agency (EMA) . April 2, 2020 . July 27, 2020 . https://web.archive.org/web/20200727011223/https://www.ema.europa.eu/en/medicines/human/EPAR/omnitrope . live .
  120. Web site: Forsteo EPAR . European Medicines Agency (EMA) . March 7, 2024 . June 27, 2020 . https://web.archive.org/web/20200627011444/https://www.ema.europa.eu/en/medicines/human/EPAR/forsteo . live .
  121. Web site: Movymia EPAR . European Medicines Agency (EMA) . April 4, 2022 . May 1, 2022 . https://web.archive.org/web/20220501163117/https://www.ema.europa.eu/en/medicines/human/EPAR/movymia . live .
  122. Web site: Terrosa EPAR . European Medicines Agency (EMA) . April 4, 2022 . August 14, 2019 . https://web.archive.org/web/20190814064635/https://www.ema.europa.eu/en/medicines/human/EPAR/terrosa . live .
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  124. Web site: Tyenne EPAR . European Medicines Agency (EMA) . March 7, 2024 . October 5, 2023 . https://web.archive.org/web/20231005035054/https://www.ema.europa.eu/en/medicines/human/EPAR/tyenne . live .
  125. Web site: Herceptin EPAR . European Medicines Agency (EMA) . July 28, 2020 . July 28, 2020 . https://web.archive.org/web/20200728160341/https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin . live .
  126. Web site: Herzuma EPAR . European Medicines Agency (EMA) . July 28, 2020 . November 8, 2020 . https://web.archive.org/web/20201108115519/https://www.ema.europa.eu/en/medicines/human/EPAR/herzuma . live .
  127. Web site: Kanjinti EPAR . European Medicines Agency (EMA) . July 28, 2020 . October 31, 2020 . https://web.archive.org/web/20201031025524/https://www.ema.europa.eu/en/medicines/human/EPAR/kanjinti . live .
  128. Web site: Ogivri EPAR . European Medicines Agency (EMA) . July 28, 2020 . March 24, 2020 . https://web.archive.org/web/20200324053621/https://www.ema.europa.eu/en/medicines/human/EPAR/ogivri . live .
  129. Web site: Ontruzant EPAR . European Medicines Agency (EMA) . July 28, 2020 . August 4, 2020 . https://web.archive.org/web/20200804092326/https://www.ema.europa.eu/en/medicines/human/EPAR/ontruzant . live .
  130. Web site: Trazimera EPAR . European Medicines Agency (EMA) . July 28, 2020 . July 28, 2020 . https://web.archive.org/web/20200728155022/https://www.ema.europa.eu/en/medicines/human/EPAR/trazimera . live .
  131. Web site: Zercepac EPAR . European Medicines Agency (EMA) . May 26, 2020 . July 28, 2020 . July 28, 2020 . https://web.archive.org/web/20200728160454/https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac . live .
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  134. Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency's biosimilars policy framework. U.S. Food and Drug Administration (FDA). December 11, 2018. December 16, 2018. May 8, 2019. 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. live.
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  136. Web site: Zarxio (filgrastim-sndz) . U.S. Food and Drug Administration (FDA) . April 20, 2015 . December 17, 2019 . December 20, 2019 . https://web.archive.org/web/20191220184811/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm . live .
  137. Web site: Inflectra (infliximab-dyyb) for Injection . U.S. Food and Drug Administration (FDA) . June 27, 2016 . November 26, 2023 . May 20, 2022 . https://web.archive.org/web/20220520044426/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125544Orig1s000TOC.cfm . live .
  138. FDA approves Erelzi, a biosimilar to Enbrel. U.S. Food and Drug Administration (FDA). December 17, 2020. August 28, 2021. https://web.archive.org/web/20210828185803/https://www.fda.gov/news-events/press-announcements/fda-approves-erelzi-biosimilar-enbrel. live.
  139. Web site: Drug Approval Package: Erelzi (etanercept-szzs) . U.S. Food and Drug Administration (FDA) . October 25, 2016 . November 26, 2023 . December 5, 2022 . https://web.archive.org/web/20221205013037/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761042Orig1_toc.cfm . live .
  140. FDA approves Amjevita, a biosimilar to Humira . U.S. Food and Drug Administration (FDA) . December 17, 2020 . November 19, 2019 . https://web.archive.org/web/20191119015605/https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira . live .
  141. Web site: Drug Approval Package: Amjevita (adalimumab-atto) . U.S. Food and Drug Administration (FDA) . November 9, 2016 . November 26, 2023 . October 4, 2020 . https://web.archive.org/web/20201004023112/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024_toc.cfm . live .
  142. Web site: Drug Approval Package: Renflexis (infliximab-abda) . U.S. Food and Drug Administration (FDA) . December 10, 2018 . December 17, 2019 . December 18, 2019 . https://web.archive.org/web/20191218044927/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761054Orig1s000TOC.cfm . live .
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  144. FDA approves first biosimilar for the treatment of cancer. U.S. Food and Drug Administration (FDA). December 17, 2020. November 5, 2021. https://web.archive.org/web/20211105130151/https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-cancer. live.
  145. Web site: Drug Approval Package: Mvasi (bevacizumab-awwb) . U.S. Food and Drug Administration (FDA) . October 10, 2018 . November 26, 2023 . February 23, 2023 . https://web.archive.org/web/20230223062038/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761028Orig1s000TOC.cfm . live .
  146. FDA approves first biosimilar for the treatment of certain breast and stomach cancers . U.S. Food and Drug Administration (FDA) . December 17, 2020 . December 15, 2019 . https://web.archive.org/web/20191215091513/https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-certain-breast-and-stomach-cancers . live .
  147. Web site: Drug Approval Package: Ogivri (Trastuzumab-dkst) . U.S. Food and Drug Administration (FDA) . November 29, 2018 . November 26, 2023 . March 22, 2023 . https://web.archive.org/web/20230322101250/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761074Orig1s000TOC.cfm . live .
  148. Web site: Drug Approval Package: Ixifi (infliximab-qbtx) . U.S. Food and Drug Administration (FDA) . November 29, 2018 . December 17, 2019 . December 18, 2019 . https://web.archive.org/web/20191218044952/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761072Orig1s000TOC.cfm . live .
  149. FDA approves first epoetin alfa biosimilar for the treatment of anemia. U.S. Food and Drug Administration (FDA). December 17, 2020. August 28, 2021. https://web.archive.org/web/20210828202332/https://www.fda.gov/news-events/press-announcements/fda-approves-first-epoetin-alfa-biosimilar-treatment-anemia. live.
  150. Web site: Drug Approval Package: Retacrit (epoetin alfa-epbx) . U.S. Food and Drug Administration (FDA) . December 13, 2018 . November 26, 2023 . September 27, 2021 . https://web.archive.org/web/20210927125923/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125545Orig1s000TOC.cfm . live .
  151. FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment . U.S. Food and Drug Administration (FDA) . December 17, 2020 . June 11, 2020 . 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 . live .
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  155. Web site: Drug Approval Package: Udenyca . U.S. Food and Drug Administration (FDA) . March 5, 2019 . December 17, 2019 . December 18, 2019 . https://web.archive.org/web/20191218045004/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761039Orig1s000TOC.cfm . live .
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  177. Web site: Drug Approval Package: Fylnetra . U.S. Food and Drug Administration (FDA) . July 15, 2022 . August 25, 2023 . September 3, 2022 . https://web.archive.org/web/20220903040614/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761084Orig1s000TOC.cfm . live .
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  179. Web site: Drug Approval Package: Stimufend . U.S. Food and Drug Administration (FDA) . November 16, 2022 . August 25, 2023 . January 26, 2023 . https://web.archive.org/web/20230126010814/http://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761173Orig1s000TOC.cfm . live .
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  182. Web site: Drug Approval Package: Yuflyma injection . U.S. Food and Drug Administration (FDA) . August 11, 2023 . August 25, 2023 . August 25, 2023 . https://web.archive.org/web/20230825223940/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761219Orig1s000TOC.cfm . live .
  183. Web site: Drug Approval Package: Tyruko . U.S. Food and Drug Administration (FDA) . October 11, 2023 . November 26, 2023 . November 26, 2023 . https://web.archive.org/web/20231126190153/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761322Orig1s000TOC.cfm . live .
  184. Web site: Drug Approval Package: Tofidence . U.S. Food and Drug Administration (FDA) . November 7, 2023 . November 26, 2023.
  185. FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases . U.S. Food and Drug Administration (FDA) . October 31, 2023 . November 13, 2023 . November 13, 2023 . https://web.archive.org/web/20231113104806/https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases . live .

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