Coherus BioSciences' (CHRS) Neulasta BLA Accepted by U.S. FDA

October 7, 2016 5:58 AM EDT

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Coherus BioSciences, Inc. (Nasdaq: CHRS) 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.

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