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FDA accepts application for Mylan/Biocon’s pegfilgrastim biosimilar Posted 24/02/2017

Mylan and Biocon announced on 16 February 2017 that the regulatory submission for their proposed pegfilgrastim biosimilar (MYL-1401H) had been accepted by the US Food and Drug Administration (FDA).

Pegfilgrastim is a 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). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

The originator product, Amgen’s Neulasta (pegfilgrastim), had 2015 sales of US$4.7 billion. The patents on Neulasta expired in the US in October 2015 and will expire in Europe in August 2017 [1].

This is not the first application for a pegfilgrastim biosimilar to be accepted for review by FDA. The agency also accepted an application from Coherus for its pegfilgrastim biosimilar candidate (CHS-1701) in October 2016 [2]. The FDA goal date set under the Biosimilar User Fee Act (BsUFA) for the review of Mylan/Biocon’s pegfilgrastim biosimilar is 9 October 2017.

Mylan and Biocon also submitted an application for their proposed pegfilgrastim biosimilar (MYL-1401H) to the European Medicines Agency (EMA) in July 2016 [3]. Meanwhile, rival biosimilars makers Coherus, Stada Arzneimittel/Gedeon Richter have also submitted marketing applications for their pegfilgrastim biosimilars to EMA [4].

Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and generic insulin analogues [5]. The proposed biosimilar pegfilgrastim is one of six biologicals being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar pegfilgrastim in Australia, Canada, Japan, New Zealand, the US, and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 24]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 24]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
3. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit pegfilgrastim biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 24]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-pegfilgrastim-biosimilar-to-EMA
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
5. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to parter on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 24]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products

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Source: Biocon, Mylan

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