FDA accepts application for pegfilgrastim biosimilar from Coherus

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FDA accepts application for pegfilgrastim biosimilar from Coherus

Biosimilars/News | Posted 11/11/2016 0 Post your comment

Coherus BioSciences (Coherus) announced on 6 October 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) for the company’s pegfilgrastim biosimilar candidate (CHS-1701).

The product is a biosimilar of Amgen’s Neulasta (pegfilgrastim). 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 BLA submission for CHS-1701 was supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS‑1701 and Neulasta. Phase I studies for CHS-1701 were completed in June 2016 and July 2015 [1]. A third phase I study of the immunogenicity of CHS-1701 compared to Neulasta was planned to be completed in December 2015, according to ClinicalTrials.gov.

Rival companies Apotex (Apobiologix; Lapelga) and Sandoz (LA-EP2006) submitted their applications for their candidate pegfilgrastim biosimilars to FDA in December 2014 [2] and November 2015 [3], respectively; and Biocon/Mylan (MYL‑1401H) and Sandoz (LA-EP2006) submitted applications for their candidate pegfilgrastim biosimilars to the European Medicines Agency in July 2016 [4] and February 2016 [5], respectively.

Coherus stated that its etanercept (CHS-0214) and adalimumab (CHS-1420) candidate biosimilars are in late stage development. The company has bevacizumab and ranibizumab candidate biosimilars, ‘as well as other product candidates’, in its pipeline [1].

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References
1. 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 2016 Nov 11]. Available from: www.gabionline.net/Biosimilars/Research/More-positive-phase-I-results-for-Coherus-pegfilgrastim-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 11]. Available from: www.gabionline.net/Biosimilars/News/Apotex-pegfilgrastim-biosimilar-under-FDA-review
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 11]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit pegfilgrastim biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 11]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-pegfilgrastim-biosimilar-to-EMA
5. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 11]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar

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Source: Coherus