The originator product, Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa), was approved by the US Food and Drug Administration (FDA) in June 1989/February 1999 and by the European Medicines Agency (EMA) in June 1989 [1]. Epogen/Eprex had worldwide sales of US$3 billion in 2015, making up US$1.9 billion in sales for Amgen and US$1.07 billion for Johnson & Johnson. Since then sales have been reduced by competition from biosimilars and in 2017 were US$2.1 billion.

The patents on Epogen/Eprex already expired in both the US and in Europe in 2013 [1], however, Amgen still has a patent protecting the cells that make certain levels of erythropoietin lasting until 26 May 2015. Some of the epoetin alfa biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

There are already three biosimilars approved for the European market and, after initial rejection [5], Hospira (Pfizer) gained approval for its epoetin alfa biosimilar, Retacrit (epoetin alfa-epbx) in the US in May 2018 [6].

Both Hospira’s Retacrit and Stada’s Silapo (epoetin zeta) biosimilars have been approved by EMA for the same indications as Aranesp (darbepoetin alfa), i.e. anaemia, cancer and chronic kidney failure, as well as for autologous blood transfusion[3].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India, ‘medicamento biológico similares’ approved in Argentina, ‘follow-on biologicals’ approved in Vietnam might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related article
Biosimilars of darbepoetin alfa

References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 13]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
3. GaBI Online - Generics and Biosimilars Initiative. Pangen gains Malaysian approval for epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 4]. Available from: www.gabionline.net/Biosimilars/News/PanGen-gains-Malaysian-approval-for-epoetin-alfa-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves epoetin alfa biosimilar Retacrit [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-epoetin-alfa-biosimilar-Retacrit
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars launched in the US at significant discount [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 4]. Available from: www.gabionline.net/Biosimilars/News/Biosimilars-launched-in-the-US-at-a-significant-discount
7. GaBI Online - Generics and Biosimilars Initiative. New administration route for epoetin alfa biosimilar Binocrit [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Biosimilars/News/New-administration-route-for-epoetin-alfa-biosimilar-Binocrit
8. GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III US trial for biosimilar epoetin alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 13]. Available from: www.gabionline.net/Biosimilars/Research/Sandoz-starts-phase-III-US-trial-for-biosimilar-epoetin-alfa

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