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Coherus Biosciences receives CRL from FDA for BLA for CHS-1701

Coherus BioSciences announced that the U.S. FDA has issued a complete response letter for its biologics license application for CHS-1701, a pegfilgrastim 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.

Read more at:
http://thefly.com/landingPageNews.php?id=2564875