Third party blamed for Coherus CRL

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Coherus BioSciences’ (Nasdaq: CHRS) application for Udenyca Onbody, the company's on-body injector (OBI) form of Udenyca (pegfilgrastim-cbqv).

Coherus stressed that the CRL had been issued solely due to an ongoing review of inspection findings at a third-party filler, and the news did not prove too damaging to the share price of the US biopharma, which is focused on developing immunotherapies to treat cancer.

"We will work with the third-party filler to address the issues and resubmit the Udenyca Onbody application as quickly as possible"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, according to a company statement put out on Monday.