The US Food and Drug Administration (FDA) approved its first epoetin alfa biosimilar on 15 May 2018.
The epoetin alfa biosimilar, Retacrit (epoetin alfa-epbx), is produced by US pharma giant Pfizer. The company received a recommendation for approval from FDA’s Oncologic Drugs Advisory Committee (ODAC) for Epoetin Hospira on 25 May 2017 [1]. The application was delayed, however, after Pfizer received a complete response letter (CRL) from FDA following manufacturing issues cited in a February 2017 FDA warning letter [2].
The product is a proposed biosimilar to Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa), which had worldwide sales of US$3 billion in 2015 [3]. Since then sales have been reduced by competition from biosimilars. The patents on Epogen expired in Europe and the US in 2013 [4], with a patent protecting the cells that make certain levels of erythropoietin expiring in May 2015 [3].
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.
Retacrit has been approved for the treatment of anaemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy.
FDA said that approval of Retacrit ‘was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity between Retacrit and US-licensed Epogen/Procrit demonstrating that Retacrit is highly similar to US-licensed Epogen/Procrit and that there are no clinically meaningful differences between the products’.
Retacrit has been approved as a biosimilar to Epogen, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
Retacrit is Pfizer’s third biosimilar to be approved in the US. The biosimilar was approved in the European Union back in 2007 [5]. The company has entered into an agreement with Vifor Pharma for the commercialization of Retacrit in ‘certain channels’.
Pfizer’s biosimilars pipeline consists of 11 distinct biosimilar molecules with six assets in mid-to-late stage clinical development.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 18]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisors-recommend-approval-of-Pfizer-s-epoetin-alfa-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA rejects Pfizer’s epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 18]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Pfizer-s-epoetin-alfa-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of epoetin alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-epoetin-alfa
4. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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