Biosimilars of epoetin alfa Posted 13/06/2014
Last update: 4 November 2019 Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.
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. Table 1: Biosimilars and non-originator biologicals* of epoetin alfa approved or in development Company name, Country Product name Stage of development Apotex (Apobiologix), Canada Apo-EPO Phase III trial in anaemia re-started Biocon, India* Erypro Safe Prefilled syringes marketed in India following 2008 launch [2] Biosidus, Argentina* Zyrop Medicamento biológico similar approved in Argentina CCM Duopharma Biotech/PanGen Biotech, Malaysia/South Korea Erisa (PDA10) Phase III trial completed in February 2017. Approved in Malaysia in February 2019 [3]. Submitted to South Korean regulatory agency (MFDS) [3] Claris Lifesciences, India* Epotin ‘Similar biologic’ marketed in India [2] Emcure, India* Epofer ‘Similar biologic’ marketed in India [2] Hexal, Australia Epoetin alfa Hexal Approved in EU in August 2007 for anaemia, cancer and chronic kidney failure [4] Hospira (Pfizer), USA Retacrit (epoetin zeta) Approved in EU in December 2007 [4]. Approved by FDA in May 2018 [5]. Launched in US in November 2018 [6]. Intas Pharmaceuticals, India* Epofit/Erykine ‘Similar biologic’ marketed in India, following 2005 launch [2] Medice Arzneimittel Pütter, Germany Abseamed Approved in EU in August 2007 for anaemia, cancer and chronic kidney failure [4] Nanogen Biopharmaceutical, Vietnam* Nanokine ‘Follow-on biological’ marketed in Vietnam Ranbaxy, India* Ceriton ‘Similar biologic’ marketed in India [2] Reliance Life Sciences, India* Relipoietin ‘Similar biologic’ marketed in India, following 2008 launch [2] Sandoz, Switzerland Binocrit Marketed in EU in August 2007 for anaemia and chronic kidney failure [4]. Approved for SC route from the EC in April 2016 [7]. Sandoz, Switzerland HX575 Phase III trial, comparing safety and efficacy of biosimilar with Epogen/Procrit in anaemia associated with chronic kidney disease started in the US in 2012 [8]. Expected completion in 2014. Stada, Germany Silapo (epoetin zeta) Approved in Europe in December 2007 [4] Wockhardt, India* Wepox ‘Similar biologic’ marketed in India, following 2001 launch [2]
EU: European Union; FDA: US Food and Drug Administration; MFDS: Ministry of Food and Drug Safety, formerly the Korean Food and Drug Administration. 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].
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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.
Biosimilars of darbepoetin alfa
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
Source: Amgen, EU Clinical Trials Register, Johnson & Johnson