FDA Issues Complete Response for Udenyca OnBody

The FDA has issued a complete response letter (CRL) for Coherus BioSciences’ biologics license application (BLA) supplement for Udenyca OnBody (pegfilgrastim-cbqv). Regulators had no issues related to clinical efficacy or safety, trial design, labeling, or device design or manufacturing, and no additional data or trials have been requested. The CRL is due to an ongoing review of inspection findings at a third-party filler.

Theresa LaVallee, Ph.D.

“We will work with the third-party filler to address the issues and resubmit the Udenyca OnBody application as quickly as possible,” Theresa LaVallee, Ph.D., Coherus chief development officer, 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 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.

Coherus also announced that the FDA has completed the clinical study site inspections of three clinical sites in China that enrolled subjects in the two pivotal clinical trials supporting the toripalimab BLA for the treatment of metastatic or recurrent nasopharyngeal carcinoma. Toripalimab, an anti-PD-1 monoclonal antibody developed by Coherus BioSciences and Shanghai Biosciences.

The FDA in May 2022 had issued a CRL and the companies resubmitted the BLA last year. But the agency has been unable to complete its review because of COVID-19 related delays in reviewing a China-based manufacturing facility.

With the inspection now complete, Coherus anticipates approval of toripalimab by the end of the year.

“Having completed all the required review elements of the toripalimab BLA, we will continue to work collaboratively with the FDA to bring toripalimab, with its substantial improvement in survival compared to chemotherapy, to NPC patients,” LaVallee said in the press release. “NPC is a rare cancer with high unmet medical need that has no drugs approved for treatment of this disease in the United States.”