Resubmission to the FDA of BLA supplement for Udenyca Onbody the on-body injector presentation of Udenyca
Coherus BioSciences, Inc. announced the Company has resubmitted the Biologics License Application (BLA) Supplement for Udenyca Onbody, biosimilar, the company's on-body injector presentation of Udenyca (pegfilgrastim-cbqv), to the FDA for review.
The resubmission of the Udencya 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.
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