US-based biosimilars developer Coherus BioSciences (Coherus) announced on 29 November 2016 that its application for approval for its proposed pegfilgrastim biosimilar (CHS 1701) had 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.
The product is a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), which had worldwide sales of US$4.7 billion in 2015. The patents on Neulasta expired in the US in October 2015 and will expire in Europe in August 2017 [1].
The submission marks the first biosimilar application from Coherus submitted to and accepted by EMA. The EMA submission is supported by biosimilarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS 1701 and Neulasta.
Coherus announced positive results from phase I trials of its pegfilgrastim biosimilar in October 2015 [2] and July 2016 [3]. The company also submitted an application for approval of its pegfilgrastim biosimilar to the US Food and Drug Administration (FDA) in October 2016 [4]. Meanwhile, rival biosimilars makers Biocon/Mylan, Stada Arzneimittel/Gedeon Richter and Sandoz have also submitted marketing applications for their pegfilgrastim biosimilars to FDA and EMA [5].
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References
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. Positive phase I results for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-pegfilgrastim-biosimilar
3. 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 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/Research/More-positive-phase-I-results-for-Coherus-pegfilgrastim-biosimilar
4. 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 Jan 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
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