Coherus announces resubmission of biologics license application supplement for Udenyca Onbody

Coherus BioSciences

5 October 2023 - Resubmission follows the satisfactory resolution of the FDA’s review of inspection findings at the third-party filler.

Coherus BioSciences today announced the Company has resubmitted the biologics license application supplement for Udenyca Onbody, the company's on-body injector presentation of Udenyca (pegfilgrastim-cbqv), to the US FDA for review.

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Michael Wonder

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Michael Wonder

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Medicine , US , Biosimilar , Dossier