Coherus Biosciences receives FDA CRL for UDENYCA ONBODY BLA

Coherus BioSciences announced that the U.S. Food and Drug Administration issued a Complete Response Letter regarding the Biologics License Application supplement for UDENYCA ONBODY, the company’s on-body injector presentation of UDENYCA, solely due to an ongoing review of inspection findings at a third-party filler. The CRL did not identify any issues with the UDENYCA ONBODY clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing, and no additional data or trials have been requested. Coherus is committed to working closely with the FDA and the third-party filler to bring UDENYCA ONBODY to cancer patients requiring pegfilgrastim treatment as quickly as possible. Coherus also announced today that the FDA has completed the clinical study site inspections of three clinical sites in China that enrolled subjects in the two pivotal clinical trials supporting the toripalimab BLA for the treatment of metastatic or recurrent nasopharyngeal carcinoma as first-line treatment or as second or greater line treatment. Only one site received an FDA Form 483, with one observation noted. Coherus believes the observation is readily addressable. Coherus continues to anticipate potential approval for toripalimab by year end 2023.