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FDA Issues Complete Response Letter (CRL) for UDENYCA® ONBODY™ Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-Party Filler; Coherus Also Announces Completion of Toripalimab FDA Inspections
– No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing were identified in the
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"– No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing were identified in the UDENYCA® ONBODY™ CRL – – No additional UDENYCA® ONBODY™ clinical data or trials have been requested by the FDA – – Toripalimab inspections completed – REDWOOD CITY, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS), a commercial-stage biopharmaceutical company focused on the research, development, and commercialization of innovative immunotherapies to treat cancer, announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) supplement for UDENYCA® ONBODY™, the company's on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), 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 completion of FDA’s toripalimab inspectionsCoherus 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 (NPC) 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. “We are pleased the FDA has completed the review elements for the OBI and toripalimab applications,” said Dr. Theresa LaVallee, Coherus Chief Development Officer. “We will work with the third-party filler to address the issues and resubmit the UDENYCA® ONBODY™ application as quickly as possible. Having completed all the required review elements of the toripalimab BLA, we will continue to work colla...