Canada-based Apotex announced on 17 December 2014 that the US Food and Drug Administration (FDA) had accepted for filing the company’s application for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).
The biosimilar has been jointly developed with India-based Intas Pharmaceuticals (Intas) and has been filed via the abbreviated approval pathway created by the Biologics Price Competition and Innovation Act (BPCIA Act) of 2009.
Pegfilgrastim is a long-acting, PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils) [1]. Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy. Apotex believes it is the first company to have a biosimilar filing accepted for review by FDA for the long-acting formulation of the product.
The originator product, Amgen’s Neulasta (pegfilgrastim), was approved by the US Food and Drug Administration (FDA) in January 2002 and by the European Medicines Agency (EMA) in August 2002 [1]. Neulasta had 2013 worldwide sales of US$5.8 billion [2], making it a lucrative target for biosimilars manufacturers, see Table 1.
The patents on Neulasta expire in the US in October 2015 and in Europe in August 2017 [1].
This is not the first collaboration between Apotex and Intas. The two companies also collaborated on a filgrastim biosimilar, resulting in the approval of Grastofil in Europe in October 2013 [3].
Intas has been marketing a pegfilgrastim ‘similar biologic’, Neupeg, in India since August 2007 [4], although the ‘similar biologic’ guidelines were released in India only in 2012 [5]. Prior to the introduction of the guidelines on ‘similar biologics’ in India, these products were approved by the RCGM and the CDSCO using an abbreviated version of the pathway applicable to new drugs on a case-by-case basis [6].
Editor’s comment
It should be noted that ‘similar biologics’ approved in India 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.
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Apotex breaking into the North American and European G-CSF markets
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 of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
3. 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: ww.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
5. GaBI Online - Generics and Biosimilars Initiative. India releases draft ‘similar biologic’ guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from:
www.gabionline.net/Guidelines/India-releases-draft-similar-biologic-guidelines
6. GaBI Online - Generics and Biosimilars Initiative. Indian guidelines for ‘similar biologics’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from: www.gabionline.net/Guidelines/Indian-guidelines-for-similar-biologics
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