Issues related to finding from an FDA inspection at a third-party filler have been resolved.
Coherus BioSciences resubmitted to the FDA the supplemental biologics license application (BLA) Udenyca OnBody, the companys on-body injector of Udenyca (pegfilgrastim-cbqv).
Last month the FDA had issued a complete response letter due to an ongoing review of inspection findings at a third-party filler. Coherus officials said the issues have been resolved, and regulators had no issues related to clinical efficacy or safety, trial design, labeling, or device design or manufacturing.
“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,” Rich Hameister, chief technical officer at Coherus, said in a press release.
Udenyca, a biosimilar of Amgen’s Neulasta, is used prevent infection after the use of chemotherapy for patients with nonmyeloid malignancies. Udenyca is currently approved with two product offerings: a prefilled syringe and autoinjector. Both products have a list price of $4,175, which Coherus BioScience says represents a 35% discount off Neulasta. Coherus BioSciences offers a copay program for $0 for up to an annual maximum of $15,000.
The auto injection version of Udenyca was approved in March 2023 and launched in May. The original version of Udenyca was approved in November 2018 and launched on the U.S. market in January 2019. It is one of six FDA-approved biosimilars referencing Neulasta.