India-based biologicals specialist USV Biologics (USV) announced on 7 December 2017 that the application for approval for its proposed pegfilgrastim biosimilar has been accepted by the European Medicines Agency (EMA).
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.
Europe is expected to be a crowded market for pegfilgrastim biosimilars. This acceptance follows another announcement by India-based biologicals specialist Biocon and US-based partner Mylan that their pegfilgrastim biosimilar (MYL 1401H) was accepted for review by EMA [1]. Spanish-based Cinfa Biotech and US-based Coherus also submitted applications for approval of pegfilgrastim biosimilars to EMA in October 2017 and November 2016, respectively [2, 3]. Sandoz also resubmitted its application to EMA for approval in October 2017 [4], and Stada Arzneimittel/Gedeon Richter submitted an application to EMA for approval back in December 2015 [5].
USV’s product is a proposed biosimilar to Amgen's Neulasta.
USV has a pipeline of seven biosimilar (products produced by recombinant biotechnology in E.coli) at various stages of development, from lab scale, clinical to market authorization.
To date, EMA has not yet approved a pegfilgrastim biosimilar.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-applications-for-pegfilgrastim-and-trastuzumab-biosimilars-from-Biocon-Mylan
2. GaBI Online - Generics and Biosimilars Initiative. More positive phase I results for Coherus pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/Research/More-positive-phase-I-results-for-Coherus-pegfilgrastim-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
5. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
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