CHS 1701 refiled with FDA for neutropenia.- Coherus BioSciences.

Coherus BioSciences announced the re-submission of its biologics license application (BLA) for CHS 1701, a pegfilgrastim (Neulasta) biosimilar candidate, for neutropenia, 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.

In June 2017, the FDA has issued a complete response letter for its biologics license application for CHS 1701 under the 351(k) pathway. The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information. The FDA did not request a clinical study to be performed in oncology patients.