Mylan and Biocon submit pegfilgrastim biosimilar to EMA

Biosimilars/News | Posted 19/08/2016 post-comment0 Post your comment

Mylan and Biocon announced on 21 July 2016 that the regulatory submission for their proposed pegfilgrastim biosimilar (MYL-1401H) had been accepted by the European Medicines Agency (EMA).

Pegfilgrastim V16B19

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].

The application is based on analytical, functional and preclinical data, and includes clinical data from pivotal pharmacokinetic/pharmacodynamic and confirmatory efficacy, safety and immunogenicity studies completed earlier in 2016. This is not the first application for a pegfilgrastim biosimilar to be accepted for review by EMA. The agency is already reviewing three other applications for adalimumab biosimilars [2].

Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and generic insulin analogues [3]. 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.

Related article
Biosimilars of pegfilgrastim

1. Derbyshire M. Patent expiry dates for best-selling biologicals, Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – April 2016 []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 19]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to partner on insulin products []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 19]. Available from:

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Source: Biocon, Mylan

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