FDA accepts Coherus’ application for Neulasta biosimilar

October 14, 2016 11:19 AM

Coherus BioSciences, Inc., a biosimilar company with late-stage clinical products, announced that the U.S. FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate.

The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta.  The biosimilar user fee act (BSUFA) action date is June 9, 2017.

The battle for biosimilars of Neulasta is ongoing in the US. Sandoz and Apotex are the first two companies who were trying to get the approval and a couple of months ago, FDA rejected Sandoz’s aBLA for pegfilgrastim biosimilar. The company stated that, it is “working with the agency to address remaining questions”. Last month, Amgen’s suits against Apotex biosimilars have failed at the district court level. On September 6, 2016, the District Court for the Southern District of Florida found no infringement by Apotex of the only remaining patent in suit, U.S. Patent 8,952,138.


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