Coherus BioSciences: FDA Issues CRL For UDENYCA ONBODY Biologics License Application

(RTTNews) - Coherus BioSciences, Inc. (CHRS) said the FDA 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 company noted that 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 also announced the FDA has completed the clinical study site inspections of three clinical sites in China that enrolled subjects in the two 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. The company said only one site received an FDA Form 483, with one observation noted. Coherus noted that the observation is readily addressable. Coherus continues to expect potential approval for toripalimab by year end 2023.

Shares of Coherus BioSciences are down 2% in pre-market trade on Monday.

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