Biosimilar

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For the journal, see Biosimilars (journal).

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.

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) 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]
Rituximab MabThera[96] Blitzima,[97] Ritemvia,[98] Rituzena,[99] Rixathon,[100] Riximyo,[101] Ruxience,[102] Truxima[103]
Somatropin Genotropin Omnitrope[104]
Teriparatide Forsteo Movymia,[105] Terrosa[106]
Trastuzumab Herceptin[107] Herzuma,[108] Kanjinti,[109] Ogivri,[110] Ontruzant,[111] Trazimera,[112] Zercepac[113]

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.[114] 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.[115]

In 2018, the FDA released a Biosimilars Action Plan to implement regulations from the BPCI, including limiting the abuse of the Risk Evaluation and Mitigation Strategy (REMS) system for evergreening and transitioning insulin and human growth hormone to regulation as biologics rather than drugs.[116]

US approved biosimilars

Date of Biosimilar FDA Approval Biosimilar Product[117] Original Product[117]
March 6, 2015[118] filgrastim-sndz/Zarxio filgrastim/Neupogen
April 5, 2016[119] infliximab-dyyb/Inflectra infliximab/Remicade
August 30, 2016[120] etanercept-szzs/Erelzi etanercept/Enbrel
September 23, 2016[121] adalimumab-atto/Amjevita adalimumab/Humira
April 21, 2017[122] infliximab-abda/Renflexis infliximab/Remicade
August 25, 2017[123] adalimumab-adbm/Cyltezo adalimumab/Humira
September 14, 2017[124] bevacizumab-awwb/Mvasi bevacizumab/Avastin
December 1, 2017[125] trastuzumab-dkst/Ogivri trastuzumab/Herceptin
December 13, 2017[126] infliximab-qbtx/Ixifi infliximab/Remicade
May 15, 2018[127] epoetin alfa-epbx/Retacrit epoetin alfa/Procrit
June 4, 2018[128] pegfilgrastim-jmdb/Fulphila pegfilgrastim/Neulasta
July 20, 2018[129] filgrastim-aafi/Nivestym filgrastim/Neupogen
October 30, 2018[130] adalimumab-adaz/Hyrimoz adalimumab/Humira
November 2, 2018[131] pegfilgrastim-cbqv/Udenyca pegfilgrastim/Neulasta
November 28, 2018[132][133][134] rituximab-abbs/Truxima rituximab/Rituxan
December 14, 2018[135] trastuzumab-pkrb/Herzuma trastuzumab/Herceptin
January 18, 2019[136] trastuzumab-dttb/Ontruzant trastuzumab/Herceptin
March 11, 2019[137] trastuzumab-qyyp/Trazimera trastuzumab/Herceptin
April 25, 2019[138] etanercept-ykro/Eticovo etanercept/Enbrel
June 13, 2019[139] trastuzumab-anns/Kanjinti trastuzumab/Herceptin
June 27, 2019[140] bevacizumab-bvzr/Zirabev bevacizumab/Avastin
July 23, 2019[141] rituximab-pvvr/Ruxience rituximab/Rituxan
July 23, 2019[142] adalimumab-bwwd/Hadlima adalimumab/Humira
November 4, 2019[143] pegfilgrastim-bmez/Ziextenzo pegfilgrastim/Neulasta
November 15, 2019[144] adalimumab-afzb/Abrilada adalimumab/Humira
December 6, 2019[145] infliximab-axxq/Avsola infliximab/Remicade
June 10, 2020[146] pegfilgrastim-apgf/Nyvepria pegfilgrastim/Neulasta
July 6, 2020[147] adalimumab-fkjp/Hulio adalimumab/Humira
December 17, 2020[148] rituximab-arrx/Riabni rituximab/Rituxan
July 28, 2021[149][150] insulin glargine-yfgn/Semglee insulin glargine/Lantus
September 17, 2021[151] ranibizumab-nuna/Byooviz ranibizumab/Lucentis
December 17, 2021[152] insulin glargine-aglr/Rezvoglar insulin glargine/Lantus
December 17, 2021[153] adalimumab-aqvh/Yusimry adalimumab/Humira
February 25, 2022[154][155] filgrastim-ayow/Releuko filgrastim/Neupogen
April 13, 2022[156][157] bevacizumab-maly/Alymsys bevacizumab/Avastin
May 26, 2022[158][159] pegfilgrastim-pbbk/Fylnetra pegfilgrastim/Neulasta
August 2, 2022[160][161] ranibizumab-eqrn/Cimerli ranibizumab/Lucentis
September 1, 2022[162] pegfilgrastim-fpgk/Stimufend pegfilgrastim/Neulasta
September 27, 2022[163][164] bevacizumab-adcd/Vegzelma bevacizumab/Avastin

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.[165] Another proposal requires originators to share the underlying cell lines.[166]

In 2019, the proposed Biologic Patent Transparency Act would help address evergreening "patent thickets" by requiring that all patents protecting a biosimilar be disclosed.[167]

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;[168] these are sometimes called the "rebate wall", and the rebates are generally unavailable to customers.[169]

Market implications

The 2012–2019 patent cliff.[170] 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.[170] 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.[170] 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.[170]

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.[171][172]

Companies

Certain companies (in some cases subsidiaries) tend to operate as generic drug manufacturers, with major ones including Teva, Mylan, and Sandoz[173] and may also extend that focus to biosimilars. Sandoz, for example, introduced the first biosimilar in the United States, and plans to introduce another in 2020.[174] 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.[175]

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. ^ a b Nick, C (2012). "The US Biosimilars Act: Challenges Facing Regulatory Approval". Pharm Med. 26 (3): 145–152. doi:10.1007/bf03262388. S2CID 14604362.
  3. ^ "Biosimilars in the EU: Information guide for healthcare professionals" (PDF). European Medicines Agency and the European Commission. 2017. Archived from the original (PDF) on October 15, 2019.
  4. ^ Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, Seidl A, Schiestl M (April 2018). "Maintaining consistent quality and clinical performance of biopharmaceuticals". Expert Opinion on Biological Therapy. 18 (4): 369–379. doi:10.1080/14712598.2018.1421169. PMID 29285958.
  5. ^ Guidelines on evaluation of similar Biotherapeutic Products (SBPs) (PDF) (Report). World Health Organization (WHO). 2009. Archived (PDF) from the original on September 29, 2021. Retrieved October 24, 2019.
  6. ^ Guidelines on evaluation of similar Biotherapeutic Products (SBPs), Annex 2, Technical Report Series No. 977 (PDF) (Report). World Health Organization (WHO). 2013. Archived (PDF) from the original on May 30, 2015. Retrieved December 18, 2019.
  7. ^ WHO Questions and Answers: Similar Biotherapeutic Products (PDF) (Report). World Health Organization (WHO). 2018. Archived (PDF) from the original on April 21, 2019. Retrieved December 18, 2019.
  8. ^ Guidelines on evaluation of monoclonal antibodies (mAbs) as similar biotherapeutic products (SBPs), Annex 2, Technical Report Series No. 1004 (PDF) (Report). World Health Organization (WHO). 2017. Archived (PDF) from the original on April 14, 2021. Retrieved December 18, 2019.
  9. ^ "Biosimilar medicines: Overview". European Medicines Agency (EMA). Archived from the original on March 29, 2020. Retrieved April 21, 2020.
  10. ^ "US Senate Committee on the Judiciary, Testimony of Dr. Lester Crawford, Acting Commissioner, FDA June 23, 2004". Archived from the original on December 28, 2016. Retrieved October 8, 2007.
  11. ^ Hearing: Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States. Subcommittee on Health Wednesday, May 2, 2007 Archived September 22, 2007, at the Wayback Machine
  12. ^ "FDA page on "Follow-On Protein Products: Regulatory and Scientific Issues Related to Developing"". U.S. Food and Drug Administration (FDA). Archived from the original on July 9, 2009.
  13. ^ "FDA page on "Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting"". U.S. Food and Drug Administration (FDA). Archived from the original on October 7, 2010.
  14. ^ "FDA Response to three Citizen Petitions against biosimilars" (PDF). U.S. Food and Drug Administration (FDA). Archived (PDF) from the original on May 31, 2017. Retrieved December 16, 2019.
  15. ^ "FDA page on "FDA approves first biosimilar product Zarxio"". U.S. Food and Drug Administration (FDA). Archived from the original on March 7, 2015.
  16. ^ a b "Statement on low-cost biosimilar and interchangeable protein products". U.S. Food and Drug Administration (FDA). December 17, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  17. ^ EMEA guideline on similar biological medicinal products Archived June 30, 2007, at the Wayback Machine
  18. ^ Warren JB (January 2013). "Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?". British Journal of Clinical Pharmacology. 75 (1): 7–14. doi:10.1111/j.1365-2125.2012.04323.x. PMC 3555041. PMID 22574725.
  19. ^ Wang X (June 1, 2014). "Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies". BioProcess International. 12 (6): 32–37. Archived from the original on January 19, 2021. Retrieved August 13, 2014.
  20. ^ Declerck PJ (February 2013). "Biosimilar monoclonal antibodies: a science-based regulatory challenge". Expert Opinion on Biological Therapy. 13 (2): 153–6. doi:10.1517/14712598.2012.758710. PMID 23286777.
  21. ^ "Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability". U.S. Food and Drug Administration (FDA). Archived from the original on September 6, 2019. Retrieved August 2, 2018.
  22. ^ a b Velásquez G (August 2018). "The International Debate on Generic Medicines of Biological Origin" (PDF). South Centre Policy Brief (50). Archived (PDF) from the original on March 6, 2021. Retrieved December 23, 2020.
  23. ^ "Australian Government Announces Decision on Biosimilar Naming Conventions". The Center For Biosimilars. Archived from the original on December 30, 2021. Retrieved December 20, 2021.
  24. ^ "Biosimilar medicines regulation". Therapeutic Goods Administration (TGA). April 4, 2018. Archived from the original on December 30, 2021. Retrieved December 29, 2021.
  25. ^ "Which biosimilar medicines are available in Australia?". Archived from the original on December 30, 2021. Retrieved December 29, 2021.
  26. ^ "Biological Qualifier". WHO. Archived from the original on March 28, 2015.
  27. ^ "WHO Report on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products" (PDF). Archived (PDF) from the original on October 31, 2017. Retrieved August 2, 2019.
  28. ^ "Which biosimilar medicines are available in Australia?". Archived from the original on December 30, 2021. Retrieved December 30, 2021.
  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]" (PDF). Biosimilars Nederland. Archived (PDF) from the original on September 19, 2020. Retrieved June 9, 2020.
  31. ^ "Amgevita EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 21, 2020.
  32. ^ "Amsparity EPAR". European Medicines Agency (EMA). Archived from the original on February 18, 2020. Retrieved April 21, 2020.
  33. ^ "Cyltezo EPAR". European Medicines Agency (EMA). Archived from the original on August 6, 2020. Retrieved August 27, 2021.
  34. ^ "Halimatoz EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 21, 2020.
  35. ^ "Hefiya EPAR". European Medicines Agency (EMA). Archived from the original on October 15, 2019. Retrieved April 21, 2020.
  36. ^ "Hukyndra EPAR". European Medicines Agency (EMA). September 14, 2021. Archived from the original on April 24, 2022. Retrieved April 23, 2022.
  37. ^ "Hulio EPAR". European Medicines Agency (EMA). Archived from the original on March 24, 2020. Retrieved April 21, 2020.
  38. ^ "Hyrimoz EPAR". European Medicines Agency (EMA). Archived from the original on November 16, 2019. Retrieved April 21, 2020.
  39. ^ "Idacio EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 21, 2020.
  40. ^ "Imraldi EPAR". European Medicines Agency (EMA). Archived from the original on March 24, 2020. Retrieved April 21, 2020.
  41. ^ "Kromeya EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved August 27, 2021.
  42. ^ "Libmyris EPAR". European Medicines Agency (EMA). September 14, 2021. Archived from the original on April 24, 2022. Retrieved April 23, 2022.
  43. ^ "Solymbic EPAR". European Medicines Agency (EMA). Archived from the original on June 25, 2019. Retrieved August 27, 2021.
  44. ^ "Trudexa EPAR". European Medicines Agency (EMA). Archived from the original on February 18, 2020. Retrieved August 27, 2021.
  45. ^ "Yuflyma EPAR". European Medicines Agency (EMA). Archived from the original on August 28, 2021. Retrieved August 27, 2021.
  46. ^ "Avastin EPAR". European Medicines Agency (EMA). Archived from the original on March 18, 2020. Retrieved September 11, 2021.
  47. ^ "Abevmy EPAR". European Medicines Agency (EMA). February 24, 2021. Archived from the original on August 28, 2021. Retrieved August 27, 2021.
  48. ^ "Alymsys EPAR". European Medicines Agency (EMA). Archived from the original on October 8, 2021. Retrieved September 11, 2021.
  49. ^ "Aybintio EPAR". European Medicines Agency (EMA). Archived from the original on December 29, 2020. Retrieved September 9, 2020.
  50. ^ "Equidacent EPAR". European Medicines Agency (EMA). Archived from the original on October 13, 2020. Retrieved October 12, 2020.
  51. ^ "Mvasi EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 2, 2020.
  52. ^ "Onbevzi EPAR". European Medicines Agency (EMA). Archived from the original on November 5, 2021. Retrieved September 11, 2021.
  53. ^ "Oyavas EPAR". European Medicines Agency (EMA). Archived from the original on October 8, 2021. Retrieved September 11, 2021.
  54. ^ "Zirabev EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 2, 2020.
  55. ^ "Inhixa EPAR". European Medicines Agency (EMA). Archived from the original on October 29, 2020. Retrieved September 9, 2020.
  56. ^ "Abseamed EPAR". European Medicines Agency (EMA). Archived from the original on March 23, 2020. Retrieved April 4, 2022.
  57. ^ "Binocrit EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  58. ^ "Epoetin Alfa Hexal EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  59. ^ "Retacrit EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  60. ^ "Silapo EPAR". European Medicines Agency (EMA). Archived from the original on October 22, 2020. Retrieved April 4, 2022.
  61. ^ "Benepali EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  62. ^ "Erelzi EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  63. ^ "Nepexto EPAR". European Medicines Agency (EMA). March 24, 2020. Archived from the original on June 4, 2020. Retrieved June 4, 2020.
  64. ^ "Accofil EPAR". European Medicines Agency (EMA). Archived from the original on March 23, 2020. Retrieved April 4, 2022.
  65. ^ "Filgrastim Hexal EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  66. ^ "Grastofil EPAR". European Medicines Agency (EMA). Archived from the original on November 12, 2020. Retrieved April 4, 2022.
  67. ^ "Nivestim EPAR". European Medicines Agency (EMA). Archived from the original on December 20, 2019. Retrieved April 4, 2022.
  68. ^ "Ratiograstim EPAR". European Medicines Agency (EMA). Archived from the original on August 14, 2020. Retrieved April 4, 2022.
  69. ^ "Tevagrastim EPAR". European Medicines Agency (EMA). Archived from the original on October 16, 2019. Retrieved April 4, 2022.
  70. ^ "Zarzio EPAR". European Medicines Agency (EMA). Archived from the original on October 15, 2019. Retrieved April 4, 2022.
  71. ^ "Bemfola EPAR". European Medicines Agency (EMA). Archived from the original on October 28, 2020. Retrieved September 9, 2020.
  72. ^ "Ovaleap EPAR". European Medicines Agency (EMA). Archived from the original on September 23, 2020. Retrieved September 9, 2020.
  73. ^ "Flixabi EPAR". European Medicines Agency (EMA). Archived from the original on October 16, 2019. Retrieved April 4, 2022.
  74. ^ "Inflectra EPAR". European Medicines Agency (EMA). Archived from the original on October 16, 2019. Retrieved April 4, 2022.
  75. ^ "Remsima EPAR". European Medicines Agency (EMA). Archived from the original on December 29, 2019. Retrieved April 4, 2022.
  76. ^ "Zessly EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  77. ^ "Fiasp EPAR". European Medicines Agency (EMA). Archived from the original on August 28, 2021. Retrieved August 27, 2021.
  78. ^ "Insulin aspart Sanofi EPAR". European Medicines Agency (EMA). Archived from the original on July 17, 2020. Retrieved September 9, 2020.
  79. ^ "Kirsty EPAR". European Medicines Agency (EMA). Archived from the original on September 15, 2021. Retrieved September 14, 2021.
  80. ^ "NovoMix EPAR". European Medicines Agency (EMA). Archived from the original on April 13, 2020. Retrieved August 27, 2021.
  81. ^ "Ryzodeg EPAR". European Medicines Agency (EMA). Archived from the original on August 28, 2021. Retrieved August 27, 2021.
  82. ^ "Abasaglar EPAR". European Medicines Agency (EMA). Archived from the original on April 2, 2022. Retrieved April 4, 2022.
  83. ^ "Semglee EPAR". European Medicines Agency (EMA). Archived from the original on February 15, 2022. Retrieved April 4, 2022.
  84. ^ "Insulin lispro Sanofi EPAR". European Medicines Agency (EMA). Archived from the original on February 24, 2020. Retrieved September 9, 2020.
  85. ^ "Neulasta EPAR". European Medicines Agency (EMA). Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  86. ^ "Cegfila (previously Pegfilgrastim Mundipharma) EPAR". European Medicines Agency (EMA). Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  87. ^ "Fulphila EPAR". European Medicines Agency (EMA). Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  88. ^ "Grasustek EPAR". European Medicines Agency (EMA). Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  89. ^ "Pelgraz EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 2, 2020.
  90. ^ "Pelmeg EPAR". European Medicines Agency (EMA). Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  91. ^ "Udenyca". European Medicines Agency (EMA. Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  92. ^ "Stimufend EPAR". European Medicines Agency (EMA). Archived from the original on April 21, 2022. Retrieved April 4, 2022.
  93. ^ "Ziextenzo EPAR". European Medicines Agency (EMA). Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  94. ^ "Lucentis EPAR". European Medicines Agency. Archived from the original on September 10, 2021. Retrieved September 9, 2021.
  95. ^ "Byooviz EPAR". European Medicines Agency. June 23, 2021. Archived from the original on September 10, 2021. Retrieved September 9, 2021.
  96. ^ "MabThera EPAR". European Medicines Agency. Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  97. ^ "Blitzima EPAR". European Medicines Agency. Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  98. ^ "Ritemvia EPAR". European Medicines Agency. Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  99. ^ "Rituzena EPAR". European Medicines Agency. Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  100. ^ "Rixathon EPAR". European Medicines Agency. Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  101. ^ "Riximyo EPAR". European Medicines Agency. Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  102. ^ "Ruxience EPAR". European Medicines Agency. Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  103. ^ "Truxima EPAR". European Medicines Agency. Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  104. ^ "Omnitrope EPAR". European Medicines Agency (EMA). Archived from the original on July 27, 2020. Retrieved April 2, 2020.
  105. ^ "Movymia EPAR". European Medicines Agency (EMA). Archived from the original on May 1, 2022. Retrieved April 4, 2022.
  106. ^ "Terrosa EPAR". European Medicines Agency (EMA). Archived from the original on August 14, 2019. Retrieved April 4, 2022.
  107. ^ "Herceptin EPAR". European Medicines Agency (EMA). Archived from the original on July 28, 2020. Retrieved July 28, 2020.
  108. ^ "Herzuma EPAR". European Medicines Agency (EMA). Archived from the original on November 8, 2020. Retrieved July 28, 2020.
  109. ^ "Kanjinti EPAR". European Medicines Agency (EMA). Archived from the original on October 31, 2020. Retrieved July 28, 2020.
  110. ^ "Ogivri EPAR". European Medicines Agency (EMA). Archived from the original on March 24, 2020. Retrieved July 28, 2020.
  111. ^ "Ontruzant EPAR". European Medicines Agency (EMA). Archived from the original on August 4, 2020. Retrieved July 28, 2020.
  112. ^ "Trazimera EPAR". European Medicines Agency (EMA). Archived from the original on July 28, 2020. Retrieved July 28, 2020.
  113. ^ "Zercepac EPAR". European Medicines Agency (EMA). Archived from the original on July 28, 2020. Retrieved July 28, 2020.
  114. ^ "Biosimilars". U.S. Food and Drug Administration. July 27, 2021. Archived from the original on August 28, 2021. Retrieved August 28, 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  115. ^ Epstein MS, Ehrenpreis ED, Kulkarni PM (December 2014). "Biosimilars: the need, the challenge, the future: the FDA perspective" (PDF). The American Journal of Gastroenterology. 109 (12): 1856–9. doi:10.1038/ajg.2014.151. PMID 24957160. S2CID 19274464. Archived from the original (PDF) on October 6, 2016. Retrieved September 25, 2016.
  116. ^ "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.
  117. ^ a b "Biosimilar Drug Information". U.S. Food and Drug Administration (FDA). Archived from the original on August 28, 2021. Retrieved August 28, 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  118. ^ "Zarxio (filgrastim-sndz)". U.S. Food and Drug Administration (FDA). April 20, 2015. Archived from the original on December 20, 2019. Retrieved December 17, 2019.
  119. ^ "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.
  120. ^ "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.
  121. ^ "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.
  122. ^ "Drug Approval Package: Renflexis (infliximab-abda)". U.S. Food and Drug Administration (FDA). December 10, 2018. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  123. ^ "Cyltezo: FDA Approved Drug Products". U.S. Food and Drug Administration (FDA). Archived from the original on February 18, 2020. Retrieved August 28, 2017.
  124. ^ "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.
  125. ^ "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.
  126. ^ "Drug Approval Package: Ixifi (infliximab-qbtx)". U.S. Food and Drug Administration (FDA). November 29, 2018. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  127. ^ "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.
  128. ^ "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.
  129. ^ "Drug Approval Package: Nivestym (filgrastim-aafi)". U.S. Food and Drug Administration (FDA). February 21, 2019. Archived from the original on December 20, 2019. Retrieved December 17, 2019.
  130. ^ "Drug Approval Package: Hyrimoz". U.S. Food and Drug Administration (FDA). March 21, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  131. ^ "Drug Approval Package: Udenyca". U.S. Food and Drug Administration (FDA). March 5, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  132. ^ "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.
  133. ^ "FDA approves first biosimilar for treatment of adult patients with non-Hodgkin's lymphoma". U.S. Food and Drug Administration. November 28, 2018. Archived from the original on December 15, 2019. Retrieved December 17, 2019.
  134. ^ "Drug Approval Package: Truxima (rituximab-abbs)". U.S. Food and Drug Administration (FDA). February 25, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  135. ^ "Drug Approval Package: Herzuma". U.S. Food and Drug Administration (FDA). February 7, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  136. ^ "Drug Approval Package: Ontruzant (trastuzumab-dttb)". U.S. Food and Drug Administration (FDA). March 5, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  137. ^ "Drug Approval Package: Trazimera (trastuzumab-qyyp)". U.S. Food and Drug Administration (FDA). May 17, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  138. ^ "Drug Approval Package: Eticovo". U.S. Food and Drug Administration (FDA). June 18, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  139. ^ "Drug Approval Package: Kanjinti". U.S. Food and Drug Administration (FDA). July 18, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  140. ^ "Drug Approval Package: Zirabev". U.S. Food and Drug Administration (FDA). August 14, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  141. ^ "Drug Approval Package: Ruxience". U.S. Food and Drug Administration (FDA). August 9, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  142. ^ "Drug Approval Package: Hadlima". U.S. Food and Drug Administration (FDA). September 5, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  143. ^ "Drug Approval Package: Ziextenzo". U.S. Food and Drug Administration (FDA). December 27, 2019. Archived from the original on June 11, 2020. Retrieved December 17, 2020.
  144. ^ "Drug Approval Package: Abrilada". U.S. Food and Drug Administration (FDA). January 28, 2020. Archived from the original on October 4, 2020. Retrieved December 17, 2020.
  145. ^ "Drug Approval Package: Avsola". U.S. Food and Drug Administration (FDA). January 30, 2020. Archived from the original on November 1, 2020. Retrieved December 17, 2020.
  146. ^ "Drug Approval Package: Nyvepria". U.S. Food and Drug Administration (FDA). August 11, 2020. Archived from the original on January 25, 2021. Retrieved December 17, 2020.
  147. ^ "Drug Approval Package: Hulio". U.S. Food and Drug Administration (FDA). October 2, 2020. Archived from the original on November 6, 2021. Retrieved December 17, 2020.
  148. ^ "Drug Approval Package: Riabni". U.S. Food and Drug Administration (FDA). January 26, 2021. Archived from the original on August 28, 2021. Retrieved August 28, 2021.
  149. ^ "Drug Approval Package: Semglee". U.S. Food and Drug Administration (FDA). September 2, 2021. Archived from the original on May 27, 2022. Retrieved May 26, 2022.
  150. ^ "FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes". U.S. Food and Drug Administration. July 30, 2021. Archived from the original on August 28, 2021. Retrieved August 28, 2021.
  151. ^ "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.
  152. ^ "Drug Approval Package: Rezvoglar". U.S. Food and Drug Administration (FDA). January 28, 2022. Archived from the original on May 27, 2022. Retrieved May 26, 2022.
  153. ^ "Drug Approval Package: Yusimry". U.S. Food and Drug Administration (FDA). January 18, 2021. Archived from the original on May 27, 2022. Retrieved May 26, 2022.
  154. ^ "Drug Approval Package: Releuko". U.S. Food and Drug Administration (FDA). April 11, 2022. Archived from the original on May 27, 2022. Retrieved May 26, 2022.
  155. ^ "Releuko- filgrastim injection, solution". DailyMed. March 11, 2022. Archived from the original on March 17, 2022. Retrieved April 4, 2022.
  156. ^ "Drug Approval Package: Alymsys". U.S. Food and Drug Administration (FDA). May 11, 2022. Archived from the original on May 27, 2022. Retrieved May 27, 2022.
  157. ^ "Alymsys- bevacizumab-maly injection, solution". DailyMed. April 13, 2022. Archived from the original on June 10, 2022. Retrieved May 26, 2022.
  158. ^ "Fylnetra: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on May 27, 2022. Retrieved May 26, 2022.
  159. ^ "Fylnetra- pegfilgrastim injection". DailyMed. May 26, 2022. Archived from the original on July 3, 2022. Retrieved September 28, 2022.
  160. ^ "Drug Approval Package: Cimerli". U.S. Food and Drug Administration (FDA). August 23, 2022. Archived from the original on September 29, 2022. Retrieved September 28, 2022.
  161. ^ "CIMERLITM (ranibizumab-eqrn) injection, for intravitreal use" (PDF). Coherus BioSciences, Inc. U.S. Food and Drug Administration. Archived (PDF) from the original on August 3, 2022. Retrieved August 3, 2022.
  162. ^ "Stimufend: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). September 1, 2022. Archived from the original on September 29, 2022. Retrieved September 2, 2022.
  163. ^ "VEGZELMA (bevacizumab-adcd) injection, for intravenous use" (PDF). CELLTRION, Inc. U.S. Food and Drug Administration. Archived (PDF) from the original on September 29, 2022. Retrieved September 29, 2022.
  164. ^ "Vegzelma: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). September 27, 2022. Archived from the original on September 29, 2022. Retrieved September 28, 2022.
  165. ^ Herper M, Silverman E (April 15, 2019). "Peter Bach's crazy idea: Give up on biosimilars. Regulate prices instead". STAT. Archived from the original on November 6, 2021. Retrieved May 16, 2019.
  166. ^ Gotham D (May 3, 2018). "Cell line access to revolutionize the biosimilars market". F1000Research. 7: 537. doi:10.12688/f1000research.14808.1. PMC 6051195. PMID 30057752.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  167. ^ "Will The Biologic Patent Transparency Act Shrink The Biosimilar Patent Dance Floor?". The National Law Review. Archived from the original on May 12, 2019. Retrieved May 16, 2019.
  168. ^ "Focus on Competition in U.S. Biosimilars Market Heats Up in Summer of 2018". JD Supra. Archived from the original on August 31, 2018. Retrieved May 19, 2019.
  169. ^ "'Rebate walls' for drugs should be dismantled by the FTC". Stat News. December 4, 2018. Archived from the original on July 26, 2020. Retrieved May 19, 2019.
  170. ^ a b c d Calo-Fernández B, Martínez-Hurtado JL (December 2012). "Biosimilars: company strategies to capture value from the biologics market". Pharmaceuticals. 5 (12): 1393–408. doi:10.3390/ph5121393. PMC 3816668. PMID 24281342.
  171. ^ "Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020". Pharmaceutical Technology. August 28, 2015. Archived from the original on July 26, 2020. Retrieved October 29, 2015.
  172. ^ Bali V (May 25, 2017). "Important Considerations When Sourcing Reference Products For Biosimilar Studies". Clinical Leader. VertMarkets. Archived from the original on December 18, 2019. Retrieved December 17, 2019. 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).
  173. ^ Stone K. "What Are the Top Generic Drug Companies?". The Balance. Archived from the original on May 18, 2019. Retrieved May 18, 2019.
  174. ^ biopharma-reporter.com. "Biosimilar entry into US insulin market will see 'millions more patients treated'". biopharma-reporter.com. Archived from the original on February 27, 2021. Retrieved May 18, 2019.
  175. ^ "'Old guard' generics players yield U.S. lead to Indian up-and-comers: analyst". FiercePharma. April 18, 2019. Archived from the original on October 20, 2020. Retrieved May 18, 2019.

Further reading

External links

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