The road to an FDA nod for Coherus BioSciences’ China-made PD-1 inhibitor has been long and tortuous.
After a complete response letter and delayed preapproval inspections, the FDA found a fresh problem at a clinical trial site for Coherus’ Junshi Biosciences-partnered toripalimab, Coherus said Monday.
The FDA’s Form 483 flagged just one observation at one of three sites in China that produced the phase 3 clinical data for toripalimab’s FDA application in nasopharyngeal carcinoma, Coherus stressed.
“Coherus believes the observation is readily addressable,” the company said. Coherus still believes an approval will come by the end of the year.
The FDA first rejected toripalimab, used alongside chemo, as a first-line nasopharyngeal cancer therapy in May 2022. At that time, the agency requested a quality process change and wasn’t able to conduct preapproval inspections in China because of COVID-related travel restrictions.
The partners immediately refiled in July 2022. Then in May 2023, Coherus said the FDA had completed the inspection of Junshi’s toriplaimab manufacturing site, but that the agency found three problems.
At each stage of its regulatory odyssey, Coherus has said the problems were “readily addressable.” But the seemingly minor tweaks and corrections have delayed the drug for more than a year now.
Meanwhile, Coherus and Junshi’s Chinese PD-1 rival, BeiGene, is also experiencing a long delay with the FDA.
After originally expecting a regulatory decision in July 2022, BeiGene has yet to receive a verdict from the FDA on its application for tislelizumab in second-line esophageal squamous cell carcinoma.
In July, BeiGene disclosed that the FDA had completed a required inspection of its tislelizumab manufacturing facility. But the uncertain approval timeline has prompted the company to file a separate new drug application in the first-line setting. As the review dragged on, BeiGene also lost Novartis as a partner.
Also on Monday, Coherus said the FDA has rejected an on-body injector presentation of Udenyca, its biosimilar referencing Amgen’s blockbuster bone marrow stimulant Neulasta. The complete response letter cited open inspection problems at a third-party filler but not the drug substance or device manufacturing, or its clinical efficacy or safety, Coherus said.
This is not the first time that Coherus hit a setback with the Neulasta copycat. The biosimilar product was rejected by the FDA in 2017 with requests for additional manufacturing-related information and a reanalysis of a subset of patient samples.
The on-body injector would be the third presentation of Coherus' Neulasta biosimilar, following an under-the-skin version and a prefilled autoinjector. In the second quarter, Udenyca generated $31.7 million in sales for Coherus.