FDA issues a Complete Response Letter to Coherus BioSciences, Inc. for CHS 1701, its pegfilgrastim (Neulasta) biosimilar candidate.

Coherus BioSciences, Inc. announced that the FDA has issued a complete response letter (“CRL”) for its biologics license application (“BLA”) for CHS 1701, a pegfilgrastim (Neulasta) biosimilar candidate, 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. Additionally, the CRL does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors. Coherus will work with the FDA to address the information requests.