Coherus Announces Resubmission of Biologics License Application (BLA) Supplement for UDENYCA ONBODY

– Resubmission follows the satisfactory resolution of the FDA’s review of inspection findings at the third-party filler –

REDWOOD CITY, Calif., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) today announced the Company has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA ONBODY, the company's on-body injector presentation of UDENYCA (pegfilgrastim-cbqv), 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 (CRL) 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.

Coherus is committed to working closely with the FDA to bring UDENYCA ONBODY to cancer patients requiring pegfilgrastim treatment as quickly as possible.

“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.

“Coherus appreciates the great collaboration with our third-party manufacturer and the swift and comprehensive actions taken to address the inspectional issues raised by the agency. We are all focused on bringing this excellent product to patients as quickly as possible,” said Rich Hameister, Chief Technical Officer at Coherus.

About Coherus BioSciences

Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology.

Through an in-licensing agreement with Shanghai Junshi Biosciences Ltd., Coherus is developing toripalimab, an anti-PD-1 antibody, in the United States and Canada. A BLA for toripalimab for the treatment of nasopharyngeal carcinoma is under review by the FDA. Toripalimab is approved in China for the treatment of melanoma, urothelial cancer, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and non-small cell lung cancer.