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.