Posted by Michael Wonder on 10 Aug 2016
Coherus BioSciences submits 351(k) biologics licence application to U.S. Food and Drug Administration for CHS-1701 (pegfilgrastim biosimilar candidate)
9 August 2016 - Coherus BioSciences today announced submission of the biologics license application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, to U.S. FDA under the 351(k) pathway.
The biologics licence application submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta.
