US-based injectables specialist Hospira announced on 12 January 2015 that it had submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its epoetin alfa biosimilar Retacrit.
Retacrit is a proposed biosimilar to Amgen’s Epogen (epoetin alfa) and Janssen’s Procrit (epoetin alfa). 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 (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 2013 worldwide sales of US$3.4 billion, making up US$2 billion in sales for Amgen and US$1.4 billion for Johnson & Johnson.
The biosimilar application for Retacrit was submitted on 16 December 2014, under the abbreviated biosimilars pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The submission marks Hospira’s first biosimilar application in the US and is the first US submission for an epoetin alfa biosimilar.
Hospira’s Retacrit (epoetin zeta) received European approval in December 2007. The company also received European approval for a biosimilar version of infliximab (Inflectra), a treatment for auto-immune diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriasis, in September 2013 [2]. Hospira also has a biosimilar version of Roche’s breast cancer blockbuster Herceptin (trastuzumab) in clinical studies and has one of the largest biosimilars pipelines in the industry, with 11 biosimilars under development [3].
FDA is currently reviewing Apotex’s application for a biosimilar version of Amgen’s Neulasta (pegfilgrastim) [4]. While on 7 January 2015, FDA advisers recommended the approval of Sandoz’s biosimilar version of Amgen’s Neupogen (filgrastim) cancer treatment [5]. All these developments lately make it seem likely that biosimilars will hit the US market sooner rather than later.
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References
1. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Hospira marks five years of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from: www.gabionline.net/Biosimilars/News/Hospira-marks-five-years-of-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from: www.gabionline.net/Biosimilars/News/Apotex-pegfilgrastim-biosimilar-under-FDA-review
5. GaBI Online - Generics and Biosimilars Initiative. FDA advisers recommend approval of filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisers-recommend-approval-of-filgrastim-biosimilar
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