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FDA rejects pegfilgrastim biosimilar from Coherus Posted 07/07/2017

Coherus BioSciences (Coherus) announced on 12 June 2017 that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its candidate pegfilgrastim biosimilar, CHS‑1701.

The product is a proposed 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 biologics license application (BLA) for CHS‑1701, which included similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS‑1701 and Neulasta, was submitted to FDA on 6 October 2016 [1].

FDA, however, rejected the BLA saying that it wanted a ‘re-analysis of a subset of subject samples with a revised immunogenicity assay’ and ‘certain additional manufacturing related process information’. Looking on the bright side, Coherus said that ‘the FDA did not request a clinical study to be performed in oncology patients. Additionally, the CRL does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors’.

The decision comes as a blow to Coherus and the company is naturally ‘disappointed in the delay that this additional request has caused’. 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. While Biocon/Mylan (MYL-1401H) and Sandoz (LA-EP2006) submitted applications for their candidate pegfilgrastim biosimilars to the European Medicines Agency (EMA) in July 2016 [4] and February 2016 [5], respectively.

Coherus also submitted an application for CHS‑1701 to EMA in November 2016 [6]. The company also said that its etanercept (CHS-0214) and adalimumab (CHS-1420) candidate biosimilars are in late stage development. It also has bevacizumab and ranibizumab candidate biosimilars, ‘as well as other product candidates’, in its pipeline [7]. 

Related article
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References
1. 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 Jul 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
2. GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. 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 2017 Jul 7]. 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 2017 Jul 7]. 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 2017 Jul 7]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
6. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
7. 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 Jul 7]. Available from: www.gabionline.net/Biosimilars/Research/More-positive-phase-I-results-for-Coherus-pegfilgrastim-biosimilar

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