Coherus announces resubmission of BLA supplement for UDENYCA ONBODY

Coherus BioSciences announced the Company has resubmitted the Biologics License Application, BLA, Supplement for UDENYCA ONBODY, the company’s on-body injector presentation of UDENYCA, to the U.S. Food and Drug Administration, FDA, for review. The resubmission of the UDENYCA ONBODY BLA Supplement follows the completion and satisfactory resolution of the FDA’s review of inspection findings at a third-party filler, which was the only issue identified in the Complete Response Letter the FDA issued on September 21, 2023. 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. “We are pleased that resolution of the FDA’s inspection findings has enabled our rapid resubmission of the UDENYCA ONBODY BLA supplement. As the CRL identified no other issues with the BLA supplement, we look forward to working closely with the agency to complete the review of the UDENYCA ONBODY application in a timely manner and anticipate potential approval later this year,” said Theresa LaVallee, Chief Development Officer of Coherus.