Coherus BioSciences said Monday that the U.S. Food and Drug Administration rejected its regulatory submission for a new on-body injector form of Udenyca, a...
Coherus BioSciences said Monday that the U.S. Food and Drug Administration rejected its regulatory submission for a new on-body injector form of Udenyca, a treatment designed to cut cancer patients’ risk of infection after chemotherapy. The rejection was due to ongoing review of inspection findings at a third-party filler and did not identify any issues with Udenyca Onbody’s clinical efficacy, safety or device design, the company said.
Coherus said it is committed to working closely with the FDA and the third-party filler to bring the new injector to patients as quickly as possible. The FDA has also completed inspections of three clinical study sites in China that enrolled subjects in two pivotal clinical trials for toripalimab for treatment of nasopharyngeal carcinoma, Coherus said. Only one inspection observation was noted, the company said, which is “readily addressable.
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