Posted by Michael Wonder on 03 May 2018
Coherus Biosciences re-submits biologics license application for CHS-1701 (pegfilgrastim biosimilar candidate)
3 May 2018 - Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the re-submission of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to the U.S. FDA under the 351(k) pathway.
The BLA is supported by similarity data from analytical, pharmacokinetic, pharmacodynamics, and immunogenicity studies comparing CHS-1701 and Neulasta and integrates new immunogenicity data obtained from using a more revised immunogenicity assay.
