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Coherus Receives CRL From FDA for Udenyca® OnBody™, Biosimilar to Amgen’s Neulasta® (pegfilgrastim)

Sep 26, 2023

Coherus Biosciences announced that the FDA issued a Complete Response Letter (CRL) for its BLA for Udenyca® OnBody™, Coherus’ on-body injector presentation of Udenyca®, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The letter relates to an ongoing review of inspection findings at a third-party filler.  The FDA did not identify issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing.

Separately, on 8 September 2023, Coherus announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company.