Biosimilar

Short description: Variant of a biopharmaceutical that is marketed following the expiry of the original patent

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.[2] Reference to the innovator product is an integral component of the approval.[3]

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.[4]

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]

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.[5][6][7][8]

The EMA has granted marketing authorizations for more than 50 biosimilars since 2006, (first approved biosimilar Somatropin (Growth hormone)). The first biosimilar of a monoclonal antibody to be approved worldwide was a biosimilar of infliximab in the EU in 2013.[9] 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.

## Contents

* 1 Approval processes
* 1.1 United States
* 2 Background
* 3 Nomenclature
* 4 Australia
* 5 European Union
* 6 United States
* 6.1 BPCI Act
* 6.2 US approved biosimilars
* 6.3 Proposed reforms
* 7 Market implications
* 8 Companies
* 9 References
* 10 Further reading
* 11 External links

## 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.[10] Additional Congressional hearings have been held.[11] On March 17, 2009, the Pathway for Biosimilars Act was introduced in the House.[2] See the Library of Congress website and search H.R. 1548 in 111th Congress Session. 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.[citation needed]

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.[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.[citation needed]

In March 2020, most protein products that were approved as drug products (including every insulin currently on the market as of December 2019[update]) 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.[16]

## 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 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.

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.[citation needed]

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]

## European Union

Biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.[29]

European Union approved biosimilars[30] Active substance | Reference product | Biosimilar medicines

|
|

Adalimumab | Humira | Amgevita,[31] Amsparity,[32] Cyltezo,[33] Halimatoz,[34] Hefiya,[35] Hukyndra,[36] Hulio,[37] Hyrimoz,[38] Idacio,[39] Imraldi,[40] Kromeya,[41] Libmyris,[42] Solymbic,[43] Trudexa,[44] Yuflyma[45]
Bevacizumab | Avastin[46] | Abevmy,[47] Alymsys,[48] Aybintio,[49] Equidacent,[50] Mvasi,[51] Onbevzi,[52] Oyavas,[53] Zirabev[54]
Enoxaparin sodium | Lovenox | Inhixa[55]
Epoetin alfa | Eprex/Erypo | Abseamed,[56] Binocrit,[57] Epoetin Alfa Hexal,[58] Retacrit,[59] Silapo[60]
Etanercept | Enbrel | Benepali,[61] Erelzi,[62] Nepexto[63]
Filgrastim | Neupogen | Accofil,[64] Filgrastim Hexal,[65] Grastofil,[66] Nivestim,[67] Ratiograstim,[68] Tevagrastim,[69] Zarzio[70]
Follitropin alfa | Gonal-F | Bemfola,[71] Ovaleap[72]
Infliximab | Remicade | Flixabi,[73] Inflectra,[74] Remsima,[75] Zessly[76]
Insulin aspart | NovoRapid | Fiasp,[77] Insulin aspart Sanofi,[78] Kirsty,[79] NovoMix,[80] Ryzodeg[81]
Insulin glargine | Lantus | Abasaglar,[82] Semglee[83]
Insulin lispro | Humalog | Insulin lispro Sanofi[84]
Pegfilgrastim | Neulasta[85] | Cegfila,[86] Fulphila,[87] Grasustek,[88] Pelgraz,[89] Pelmeg,[90] Udenyca,[91] Stimufend,[92] Ziextenzo[93]
Ranibizumab | Lucentis[94] | Byooviz,[95] Ranivisio,[96] Ximluci[97]
Rituximab | MabThera[98] | Blitzima,[99] Ritemvia,[100] Rituzena,[101] Rixathon,[102] Riximyo,[103] Ruxience,[104] Truxima[105]
Somatropin | Genotropin | Omnitrope[106]
Teriparatide | Forsteo | Movymia,[107] Terrosa[108]
Trastuzumab | Herceptin[109] | Herzuma,[110] Kanjinti,[111] Ogivri,[112] Ontruzant,[113] Trazimera,[114] Zercepac[115]

## 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.[116] 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.[117]

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.[118]

### US approved biosimilars

Date of Biosimilar FDA Approval | Biosimilar Product[119] | Original Product[119]

|
|

March 6, 2015[120] | filgrastim-sndz/Zarxio | filgrastim/Neupogen
April 5, 2016[121] | infliximab-dyyb/Inflectra | infliximab/Remicade
August 30, 2016[122] | etanercept-szzs/Erelzi | etanercept/Enbrel
September 23, 2016[123] | adalimumab-atto/Amjevita | adalimumab/Humira
April 21, 2017[124] | infliximab-abda/Renflexis | infliximab/Remicade
August 25, 2017[125] | adalimumab-adbm/Cyltezo | adalimumab/Humira
September 14, 2017[126] | bevacizumab-awwb/Mvasi | bevacizumab/Avastin
December 1, 2017[127] | trastuzumab-dkst/Ogivri | trastuzumab/Herceptin
December 13, 2017[128] | infliximab-qbtx/Ixifi | infliximab/Remicade
May 15, 2018[129] | epoetin alfa-epbx/Retacrit | epoetin alfa/Procrit
June 4, 2018[130] | pegfilgrastim-jmdb/Fulphila | pegfilgrastim/Neulasta
July 20, 2018[131] | filgrastim-aafi/Nivestym | filgrastim/Neupogen
October 30, 2018[132] | adalimumab-adaz/Hyrimoz | adalimumab/Humira
November 2, 2018[133] | pegfilgrastim-cbqv/Udenyca | pegfilgrastim/Neulasta
November 28, 2018[134][135][136] | rituximab-abbs/Truxima | rituximab/Rituxan
December 14, 2018[137] | trastuzumab-pkrb/Herzuma | trastuzumab/Herceptin
January 18, 2019[138] | trastuzumab-dttb/Ontruzant | trastuzumab/Herceptin
March 11, 2019[139] | trastuzumab-qyyp/Trazimera | trastuzumab/Herceptin
April 25, 2019[140] | etanercept-ykro/Eticovo | etanercept/Enbrel
June 13, 2019[141] | trastuzumab-anns/Kanjinti | trastuzumab/Herceptin
June 27, 2019[142] | bevacizumab-bvzr/Zirabev | bevacizumab/Avastin
July 23, 2019[143] | rituximab-pvvr/Ruxience | rituximab/Rituxan
July 23, 2019[144] | adalimumab-bwwd/Hadlima | adalimumab/Humira
November 4, 2019[145] | pegfilgrastim-bmez/Ziextenzo | pegfilgrastim/Neulasta
November 15, 2019[146] | adalimumab-afzb/Abrilada | adalimumab/Humira
December 6, 2019[147] | infliximab-axxq/Avsola | infliximab/Remicade
June 10, 2020[148] | pegfilgrastim-apgf/Nyvepria | pegfilgrastim/Neulasta
July 6, 2020[149] | adalimumab-fkjp/Hulio | adalimumab/Humira
December 17, 2020[150] | rituximab-arrx/Riabni | rituximab/Rituxan
July 28, 2021[151][152] | insulin glargine-yfgn/Semglee | insulin glargine/Lantus
September 17, 2021[153] | ranibizumab-nuna/Byooviz | ranibizumab/Lucentis
December 17, 2021[154] | insulin glargine-aglr/Rezvoglar | insulin glargine/Lantus
December 17, 2021[155] | adalimumab-aqvh/Yusimry | adalimumab/Humira
February 25, 2022[156][157] | filgrastim-ayow/Releuko | filgrastim/Neupogen
April 13, 2022[158][159] | bevacizumab-maly/Alymsys | bevacizumab/Avastin
May 26, 2022[160][161] | pegfilgrastim-pbbk/Fylnetra | pegfilgrastim/Neulasta
August 2, 2022[162][163] | ranibizumab-eqrn/Cimerli | ranibizumab/Lucentis
September 1, 2022[164] | pegfilgrastim-fpgk/Stimufend | pegfilgrastim/Neulasta
September 27, 2022[165][166] | bevacizumab-adcd/Vegzelma | bevacizumab/Avastin
December 13, 2022 | adalimumab-aacf/Idacio | adalimumab/Humira

### Proposed reforms

In the United States, biosimilars have not had the expected impact on prices, leading a 2019 proposal to price regulate instead after an exclusivity period.[167] Another proposal requires originators to share the underlying cell lines.[168]

In 2019, the proposed Biologic Patent Transparency Act would help address evergreening "patent thickets" by requiring that all patents protecting a biosimilar be disclosed.[169]

Biosimilars have found it difficult to get market share, which led biosimilar developer Pfizer to sue Johnson & Johnson over anticompetitive contracts with pharmacy benefit managers which bundle discounts;[170] these are sometimes called the "rebate wall", and the rebates are generally unavailable to customers.[171]

## Market implications

The 2012–2019 patent cliff.[172] Period of market exclusivity up to date of patent expiration for the ten top-selling biologics for 2011. *Enbrel has been granted approval in 2011 for a patent filed in 1995, extending its patent life further 17 years.

The legal requirements of approval pathways, together with the costly manufacturing processes, escalates the developing costs for biosimilars that could be between $75–$250 million per molecule.[172] This market entry barrier affects not only the companies willing to produce them but could also delay availability of inexpensive alternatives for public healthcare institutions that subsidize treatment for their patients. Even though the biosimilars market is rising, the price drop for biological drugs at risk of patent expiration will not be as great as for other generic drugs; in fact it has been estimated that the price for biosimilar products will be 65%-85% of their originators.[172] Biosimilars are drawing market's attention since there is an upcoming patent cliff, which will put nearly 36% of the $140 billion market for biologic drugs at risk (as of 2011), this considering only the top 10 selling products.[172]

The global biosimilars market was US$1.3 billion in 2013, and is expected to reach US$35 billion by 2020, driven by the patent expiration of additional ten blockbuster biologic drugs.[173][174]

## Companies

Certain companies (in some cases subsidiaries) tend to operate as generic drug manufacturers, with major ones including Teva, Viatris, and Sandoz[175] and may also extend that focus to biosimilars. Sandoz, for example, introduced the first biosimilar in the United States.[176] By value the most important biosimilar business is run by Celltrion (South Korea).[177] Newer companies such as India-based Cadila Pharmaceuticals, Sun Pharma, Aurobindo Pharma, Lupin and Dr. Reddy's Laboratories as well as Canada-based Apotex have taken share in traditional generics, which has led older companies to shift their focus to complex drugs such as biosimilars.[178]

## 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. ↑ 2.0 2.1 Nick, C (2012). "The US Biosimilars Act: Challenges Facing Regulatory Approval". Pharm Med 26 (3): 145–152. doi:10.1007/bf03262388.
3. ↑ "Biosimilars in the EU: Information guide for healthcare professionals". European Medicines Agency and the European Commission. 2017. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf.
4. ↑ "Maintaining consistent quality and clinical performance of biopharmaceuticals". Expert Opinion on Biological Therapy 18 (4): 369–379. April 2018. doi:10.1080/14712598.2018.1421169. PMID 29285958.
5. ↑ ﻿Guidelines on evaluation of similar Biotherapeutic Products (SBPs)﻿ (Report). World Health Organization (WHO). 2009. https://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Retrieved October 24, 2019.
6. ↑ ﻿Guidelines on evaluation of similar Biotherapeutic Products (SBPs), Annex 2, Technical Report Series No. 977﻿ (Report). World Health Organization (WHO). 2013. https://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf?ua=1. Retrieved December 18, 2019.
7. ↑ ﻿WHO Questions and Answers: Similar Biotherapeutic Products﻿ (Report). World Health Organization (WHO). 2018. https://www.who.int/biologicals/expert_committee/QA_for_SBPs_ECBS_2018.pdf?ua=1. Retrieved December 18, 2019.
8. ↑ ﻿Guidelines on evaluation of monoclonal antibodies (mAbs) as similar biotherapeutic products (SBPs), Annex 2, Technical Report Series No. 1004﻿ (Report). World Health Organization (WHO). 2017. https://www.who.int/biologicals/biotherapeutics/WHO_TRS_1004_web_Annex_2.pdf?ua=1. Retrieved December 18, 2019.
9. ↑ "Biosimilar medicines: Overview". September 17, 2018. https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview.
10. ↑ "US Senate Committee on the Judiciary, Testimony of Dr. Lester Crawford, Acting Commissioner, FDA June 23, 2004". http://judiciary.senate.gov/testimony.cfm?id=1239&wit_id=3623.
11. ↑ Hearing: Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States. Subcommittee on Health Wednesday, May 2, 2007
12. ↑ "FDA page on "Follow-On Protein Products: Regulatory and Scientific Issues Related to Developing"". https://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ucm085854.htm.
13. ↑ "FDA page on "Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting"". https://www.fda.gov/Drugs/NewsEvents/ucm221688.htm.
14. ↑ "FDA Response to three Citizen Petitions against biosimilars". https://www.fda.gov/ohrms/dockets/dockets/04P0231/04P-0231-pdn0001.pdf.
15. ↑ "FDA page on "FDA approves first biosimilar product Zarxio"". https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm.
16. ↑ 16.0 16.1 "Statement on low-cost biosimilar and interchangeable protein products". December 17, 2019. https://www.fda.gov/news-events/press-announcements/statement-low-cost-biosimilar-and-interchangeable-protein-products. This article incorporates text from this source, which is in the public domain.
17. ↑ EMEA guideline on similar biological medicinal products
18. ↑ "Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?". British Journal of Clinical Pharmacology 75 (1): 7–14. January 2013. doi:10.1111/j.1365-2125.2012.04323.x. PMID 22574725.
19. ↑ "Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies". BioProcess International 12 (6): 32–37. June 1, 2014. http://www.bioprocessintl.com/manufacturing/biosimilars/higher-order-structure-comparability/. Retrieved August 13, 2014.
20. ↑ "Biosimilar monoclonal antibodies: a science-based regulatory challenge". Expert Opinion on Biological Therapy 13 (2): 153–6. February 2013. doi:10.1517/14712598.2012.758710. PMID 23286777.
21. ↑ "Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability". https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonproprietary-naming-biological-products-update-guidance-industry.
22. ↑ 22.0 22.1 "The International Debate on Generic Medicines of Biological Origin". South Centre Policy Brief (50). August 2018. https://www.southcentre.int/wp-content/uploads/2018/08/PB50_The-International-Debate-on-Generic-Medicines-of-Biological-Origin_EN.pdf. Retrieved December 23, 2020.
23. ↑ "Australian Government Announces Decision on Biosimilar Naming Conventions". https://www.centerforbiosimilars.com/view/australian-government-announces-decision-on-biosimilar-naming-conventions.
24. ↑ "Biosimilar medicines regulation". April 4, 2018. https://www.tga.gov.au/publication/biosimilar-medicines-regulation.
25. ↑ "Which biosimilar medicines are available in Australia?". https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia.
26. ↑ "Biological Qualifier". https://www.who.int/medicines/services/inn/inn_bio_bq/en/.
27. ↑ "WHO Report on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products". https://www.who.int/medicines/access/biotherapeutics/FINAL_Report-improving-access-to-and-use-of-biotherapeutics_October2017.pdf.
28. ↑ "Which biosimilar medicines are available in Australia?". https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia.
29. ↑ "Biosimilar medicines can be interchanged". European Medicines Agency (EMA) (Press release). September 19, 2022. Archived from the original on September 20, 2022. Retrieved September 19, 2022.
30. ↑ "EU Approved biosimilars by molecule [data arranged from EMA website"]. https://www.biosimilars-nederland.nl/wp-content/uploads/2020_06_01-Table-EU-licensed-biosimilars-by-molecule_May_2020agv.pdf.
31. ↑ "Amgevita EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita.
32. ↑ "Amsparity EPAR". December 9, 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/amsparity.
33. ↑ "Cyltezo EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/cyltezo.
34. ↑ "Halimatoz EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/halimatoz.
35. ↑ "Hefiya EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/hefiya.
36. ↑ "Hukyndra EPAR". September 14, 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra.
37. ↑ "Hulio EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/hulio.
38. ↑ "Hyrimoz EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz.
39. ↑ "Idacio EPAR". January 29, 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/idacio.
40. ↑ "Imraldi EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/imraldi.
41. ↑ "Kromeya EPAR". January 29, 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/kromeya.
42. ↑ "Libmyris EPAR". September 14, 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris.
43. ↑ "Solymbic EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/solymbic.
44. ↑ "Trudexa EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/trudexa.
45. ↑ "Yuflyma EPAR". December 9, 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma.
46. ↑ "Avastin EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/avastin.
47. ↑ "Abevmy EPAR". February 24, 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/abevmy.
48. ↑ "Alymsys EPAR". January 25, 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/alymsys.
49. ↑ "Aybintio EPAR". May 26, 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/aybintio.
50. ↑ "Equidacent EPAR". July 20, 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/equidacent.
51. ↑ "Mvasi EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/mvasi.
52. ↑ "Onbevzi EPAR". November 9, 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/onbevzi.
53. ↑ "Oyavas EPAR". January 25, 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/oyavas.
54. ↑ "Zirabev EPAR". December 11, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/zirabev.
55. ↑ "Inhixa EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/inhixa.
56. ↑ "Abseamed EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/abseamed.
57. ↑ "Binocrit EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/binocrit.
58. ↑ "Epoetin Alfa Hexal EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/epoetin-alfa-hexal.
59. ↑ "Retacrit EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/retacrit.
60. ↑ "Silapo EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/silapo.
61. ↑ "Benepali EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/benepali.
62. ↑ "Erelzi EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/erelzi.
63. ↑ "Nepexto EPAR". March 24, 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/nepexto.
64. ↑ "Accofil EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/accofil.
65. ↑ "Filgrastim Hexal EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-hexal.
66. ↑ "Grastofil EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/grastofil.
67. ↑ "Nivestim EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/nivestim.
68. ↑ "Ratiograstim EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/ratiograstim.
69. ↑ "Tevagrastim EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/tevagrastim.
70. ↑ "Zarzio EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio.
71. ↑ "Bemfola EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/bemfola.
72. ↑ "Ovaleap EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/ovaleap.
73. ↑ "Flixabi EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/flixabi.
74. ↑ "Inflectra EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/inflectra.
75. ↑ "Remsima EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/remsima.
76. ↑ "Zessly EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/zessly.
77. ↑ "Fiasp EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/Fiasp.
78. ↑ "Insulin aspart Sanofi EPAR". April 28, 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-aspart-sanofi.
79. ↑ "Kirsty EPAR". December 9, 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/kirsty-previously-kixelle.
80. ↑ "NovoMix EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/NovoMix.
81. ↑ "Ryzodeg EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/Ryzodeg.
82. ↑ "Abasaglar EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/abasaglar-previously-abasria.
83. ↑ "Semglee EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/semglee.
84. ↑ "Insulin lispro Sanofi EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/insulin-lispro-sanofi.
85. ↑ "Neulasta EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta.
86. ↑ "Cegfila (previously Pegfilgrastim Mundipharma) EPAR". October 16, 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/cegfila.
87. ↑ "Fulphila EPAR". September 24, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila-0.
88. ↑ "Grasustek EPAR". April 24, 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek.
89. ↑ "Pelgraz EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz.
90. ↑ "Pelmeg EPAR". September 24, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg.
91. ↑ "Udenyca". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/udenyca.
92. ↑ "Stimufend EPAR". January 24, 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend.
93. ↑ "Ziextenzo EPAR". September 24, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo.
94. ↑ "Lucentis EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/lucentis.
95. ↑ "Byooviz EPAR". June 23, 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/byooviz.
96. ↑ "Ranivisio EPAR". 20 June 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/ranivisio.
97. ↑ "Ximluci EPAR". 14 September 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/ximluci.
98. ↑ "MabThera EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/mabthera.
99. ↑ "Blitzima EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/blitzima.
100. ↑ "Ritemvia EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/ritemvia.
101. ↑ "Rituzena EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/rituzena-previously-tuxella.
102. ↑ "Rixathon EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/rixathon.
103. ↑ "Riximyo EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/riximyo.
104. ↑ "Ruxience EPAR". January 29, 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/ruxience.
105. ↑ "Truxima EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/truxima.
106. ↑ "Omnitrope EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/omnitrope.
107. ↑ "Movymia EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/movymia.
108. ↑ "Terrosa EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/terrosa.
109. ↑ "Herceptin EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin.
110. ↑ "Herzuma EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/herzuma.
111. ↑ "Kanjinti EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/kanjinti.
112. ↑ "Ogivri EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/ogivri.
113. ↑ "Ontruzant EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/ontruzant.
114. ↑ "Trazimera EPAR". September 17, 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/trazimera.
115. ↑ "Zercepac EPAR". May 26, 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac.
116. ↑ "Biosimilars". July 27, 2021. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars. This article incorporates text from this source, which is in the public domain.
117. ↑ "Biosimilars: the need, the challenge, the future: the FDA perspective". The American Journal of Gastroenterology 109 (12): 1856–9. December 2014. doi:10.1038/ajg.2014.151. PMID 24957160. http://gi.org/wp-content/uploads/2015/01/FDA_Biosimilars_December_2014.pdf. Retrieved September 25, 2016.
118. ↑ "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) (Press release). December 11, 2018. Archived from the original on May 8, 2019. Retrieved December 16, 2018.
119. ↑ 119.0 119.1 "Biosimilar Drug Information". https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. This article incorporates text from this source, which is in the public domain.
120. ↑ "Zarxio (filgrastim-sndz)". April 20, 2015. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm.
121. ↑ "FDA approves Inflectra, a biosimilar to Remicade". U.S. Food and Drug Administration (FDA) (Press release). Archived from the original on December 7, 2019. Retrieved December 17, 2020.
122. ↑ "FDA approves Erelzi, a biosimilar to Enbrel". U.S. Food and Drug Administration (FDA) (Press release). Archived from the original on August 28, 2021. Retrieved December 17, 2020.
123. ↑ "FDA approves Amjevita, a biosimilar to Humira". U.S. Food and Drug Administration (FDA) (Press release). Archived from the original on November 19, 2019. Retrieved December 17, 2020.
124. ↑ "Drug Approval Package: Renflexis (infliximab-abda)". December 10, 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761054Orig1s000TOC.cfm.
125. ↑ "Cyltezo: FDA Approved Drug Products". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761058.
126. ↑ "FDA approves first biosimilar for the treatment of cancer". U.S. Food and Drug Administration (FDA) (Press release). Archived from the original on November 5, 2021. Retrieved December 17, 2020.
127. ↑ "FDA approves first biosimilar for the treatment of certain breast and stomach cancers". U.S. Food and Drug Administration (FDA) (Press release). Archived from the original on December 15, 2019. Retrieved December 17, 2020.
128. ↑ "Drug Approval Package: Ixifi (infliximab-qbtx)". November 29, 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761072Orig1s000TOC.cfm.
129. ↑ "FDA approves first epoetin alfa biosimilar for the treatment of anemia". U.S. Food and Drug Administration (FDA) (Press release). Archived from the original on August 28, 2021. Retrieved December 17, 2020.
130. ↑ "FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment". U.S. Food and Drug Administration (FDA) (Press release). Archived from the original on June 11, 2020. Retrieved December 17, 2020.
131. ↑ "Drug Approval Package: Nivestym (filgrastim-aafi)". February 21, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761080Orig1s000TOC.cfm.
132. ↑ "Drug Approval Package: Hyrimoz". March 21, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761071Orig1s000TOC.cfm.
133. ↑ "Drug Approval Package: Udenyca". March 5, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761039Orig1s000TOC.cfm.
134. ↑ "FDA approves Truxima as biosimilar to Rituxan for non-Hodgkin's lymphoma". U.S. Food and Drug Administration (Press release). November 28, 2018. Archived from the original on December 16, 2019. Retrieved December 17, 2019.
135. ↑ "FDA approves first biosimilar for treatment of adult patients with non-Hodgkin's lymphoma". November 28, 2018. http://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-adult-patients-non-hodgkins-lymphoma.
136. ↑ "Drug Approval Package: Truxima (rituximab-abbs)". February 25, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761088Orig1s000TOC.cfm.
137. ↑ "Drug Approval Package: Herzuma". February 7, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761091Orig1s000TOC.cfm.
138. ↑ "Drug Approval Package: Ontruzant (trastuzumab-dttb)". March 5, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761100Orig1s000TOC.cfm.
139. ↑ "Drug Approval Package: Trazimera (trastuzumab-qyyp)". May 17, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761081Orig1s000TOC.cfm.
140. ↑ "Drug Approval Package: Eticovo". June 18, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761066Orig1s000TOC.cfm.
141. ↑ "Drug Approval Package: Kanjinti". July 18, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761073Orig1s000TOC.cfm.
142. ↑ "Drug Approval Package: Zirabev". August 14, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761099Orig1s000TOC.cfm.
143. ↑ "Drug Approval Package: Ruxience". August 9, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761103Orig1s000TOC.cfm.
144. ↑ "Drug Approval Package: Hadlima". September 5, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761059Orig1s000TOC.cfm.
145. ↑ "Drug Approval Package: Ziextenzo". December 27, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761045Orig1s000TOC.cfm.
146. ↑ "Drug Approval Package: Abrilada". January 28, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761118Orig1s000TOC.cfm.
147. ↑ "Drug Approval Package: Avsola". January 30, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761086Orig1s000TOC.cfm.
148. ↑ "Drug Approval Package: Nyvepria". August 11, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761111Orig1s000TOC.cfm.
149. ↑ "Drug Approval Package: Hulio". October 2, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761154Orig1s000TOC.cfm.
150. ↑ "Drug Approval Package: Riabni". January 26, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761140Orig1s000TOC.cfm.
151. ↑ "Drug Approval Package: Semglee". September 2, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761201Orig1s000TOC.cfm.
152. ↑ "FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes". July 30, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes.
153. ↑ "FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions". U.S. Food and Drug Administration (FDA) (Press release). September 20, 2021. Archived from the original on September 20, 2021. Retrieved September 20, 2021.
154. ↑ "Drug Approval Package: Rezvoglar". January 28, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761215Orig1s000TOC.cfm.
155. ↑ "Drug Approval Package: Yusimry". January 18, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761216Orig1s000TOC.cfm.
156. ↑ "Drug Approval Package: Releuko". April 11, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761082Orig1s000TOC.cfm.
157. ↑ "Releuko- filgrastim injection, solution". March 11, 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=74e1ec6e-1630-4654-895c-2bd355f939e7.
158. ↑ "Drug Approval Package: Alymsys". May 11, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761231Orig1s000TOC.cfm.
159. ↑ "Alymsys- bevacizumab-maly injection, solution". April 13, 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6b4040a2-a5c5-4ff0-ab45-935d7e49cf78.
160. ↑ "Fylnetra: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761084.
161. ↑ "Fylnetra- pegfilgrastim injection". May 26, 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeadd641-573d-47fe-897a-61006e5f9e03.
162. ↑ "Drug Approval Package: Cimerli". U.S. Food and Drug Administration (FDA). August 23, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761165Orig1s000TOC.cfm.
163. ↑ "CIMERLITM (ranibizumab-eqrn) injection, for intravitreal use". Coherus BioSciences, Inc.. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761165s000lbl.pdf.
164. ↑ "Stimufend: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). September 1, 2022. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761173.
165. ↑ "VEGZELMA (bevacizumab-adcd) injection, for intravenous use". CELLTRION, Inc.. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761268s000lbl.pdf.
166. ↑ "Vegzelma: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). September 27, 2022. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761268.
167. ↑ "Peter Bach's crazy idea: Give up on biosimilars. Regulate prices instead". April 15, 2019. https://www.statnews.com/2019/04/15/peter-bachs-latest-crazy-idea-give-up-on-biosimilars-regulate-drug-prices-instead/.
168. ↑ "Cell line access to revolutionize the biosimilars market". F1000Research 7: 537. May 3, 2018. doi:10.12688/f1000research.14808.1. PMID 30057752.
169. ↑ "Will The Biologic Patent Transparency Act Shrink The Biosimilar Patent Dance Floor?". https://www.natlawreview.com/article/will-biologic-patent-transparency-act-shrink-biosimilar-patent-dance-floor.
170. ↑ "Focus on Competition in U.S. Biosimilars Market Heats Up in Summer of 2018". https://www.jdsupra.com/legalnews/focus-on-competition-in-u-s-biosimilars-20266/.
171. ↑ "'Rebate walls' for drugs should be dismantled by the FTC". December 4, 2018. https://www.statnews.com/2018/12/04/ftc-dismantle-drug-rebate-walls/.
172. ↑ 172.0 172.1 172.2 172.3 "Biosimilars: company strategies to capture value from the biologics market". Pharmaceuticals 5 (12): 1393–408. December 2012. doi:10.3390/ph5121393. PMID 24281342.
173. ↑ "Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020". Pharmaceutical Technology. August 28, 2015. http://www.pharmtech.com/biosimilars-and-follow-biologics-market-hit-35-billion-globally-2020.
174. ↑ "Important Considerations When Sourcing Reference Products For Biosimilar Studies". Clinical Leader (VertMarkets). May 25, 2017. https://www.clinicalleader.com/doc/important-considerations-when-sourcing-reference-products-for-biosimilar-studies-0001. "As a slew of the most important, most widely-used and accepted biologics have their patents expire this decade, the biosimilar market is predicted to leap from $1.36 billion in 2013, to over $35 billion by 2020 (Allied Market Research)."
175. ↑ "What Are the Top Generic Drug Companies?". https://www.thebalance.com/top-generic-drug-companies-2663110.
176. ↑ biopharma-reporter.com. "Biosimilar entry into US insulin market will see 'millions more patients treated'". https://www.biopharma-reporter.com/Article/2019/02/11/Sandoz-readies-insulin-biosimilars-for-US.
177. ↑ "Top Global Pharmaceutical Company Report". The Pharma 1000. November 2021. https://torreya.com/publications/pharma-1000-report-update-torreya-2021-11-18.pdf.
178. ↑ "'Old guard' generics players yield U.S. lead to Indian up-and-comers: analyst". Fierce Pharma. April 18, 2019. https://www.fiercepharma.com/pharma/generics-old-guard-pack-yields-u-s-scripts-lead-to-next-6-led-by-indian-firms-analyst.

## Further reading

* "Monoclonal antibody biosimilars". Nature Reviews. Drug Discovery 15 (1): 13–4. January 2016. doi:10.1038/nrd.2015.12. PMID 26678619.
* "Biosimilar epoetins and other "follow-on" biologics: update on the European experiences". American Journal of Hematology 85 (10): 771–80. October 2010. doi:10.1002/ajh.21805. PMID 20706990. https://hal.archives-ouvertes.fr/hal-00552331/document.
* "New guide on biosimilar medicines for healthcare professionals". Prepared Jointly by the European Medicines Agency and the European Commission. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/05/news_detail_002739.jsp&mid=WC0b01ac058004d5c1. Retrieved May 10, 2017.
* "What's keeping less expensive biologic drugs from the U.S. market?". PBS NewsHour. April 19, 2014. https://www.pbs.org/newshour/bb/whats-keeping-generic-version-biologic-drugs-u-s-market/.
* "Biosimilars or Biologics: What's the difference?". Therapeutics Letter 123.. November 2019. https://www.ti.ubc.ca/2019/11/11/123-biosimilars-or-biologics-whats-the-difference/.

## External links

* Overview of Biosimilar Products U.S. Food and Drug Administration
* Biosimilar Regulatory Review and Approval  U.S. Food and Drug Administration
* Interchangeable Biological Products  U.S. Food and Drug Administration

0.00

(0 votes)

|

Retrieved from "https://handwiki.org/wiki/index.php?title=Biology:Biosimilar&oldid=373715"