What happened
Shares of Coherus BioSciences (CHRS 5.70%) rose 9.4% on Thursday after the biotech resubmitted a biologic license application (BLA) supplement for a key product to the U.S. Food and Drug Administration (FDA) for review.
So what
Coherus stock came under pressure late last month after the FDA issued a complete response letter (CRL) for the company's Udenyca On-Body biologics license application. That effectively held up Coherus' plans to commercialize Udenyca, its biosimilar to pegfilgrastim, which helps prevent infections in patients being treated for cancer.
But the issue was related to an ongoing review at a third-party manufacturing site, and Coherus was quick to point out that the FDA did not raise any concerns about Udenyca's labeling, efficacy, or safety.
In a press release earlier today, Coherus announced it has resubmitted the biologics license application in question following the completion and satisfactory resolution of the FDA's review.
Now what
Coherus added that no extra data or trials have been requested by the FDA, noting that it's "committed to working closely with the FDA to bring Udenyca On-Body to cancer patients requiring pegfilgrastim treatment as quickly as possible." Assuming all else goes as planned, the company expects Udenyca On-Body to be formally approved by the FDA later this year.
