Coherus Receives FDA’s Complete Response Letter for its Pegfilgrastim Biosimilar

Coherus BioSciences, Inc. announced this morning that the FDA has issued a complete response letter (“CRL”) for its biologics license application for its pegfilgrastim (Neulasta®) biosimilar.  According to Coherus, “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” and “did not request a clinical study to be performed in oncology patients.”  According to the President and CEO of Coherus, the company is “disappointed in the delay that this additional request has caused” but remains “confident in our ability to address the FDA’s requests for the purpose of obtaining approval for CHS-1701,” Coherus’s pegfilgrastim biosimilar.

The Coherus management team is hosting a conference call this morning.  We will continue to monitor this development, so check back for further updates.