FDA Approves First Biosimilar for Neulasta Onpro

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The FDA has approved Coherus Biosciences’ on-body injector version of Udenyca (pegfilgrastim-cbqv), making it the first biosimilar to reference Neulasta Onpro, the pegfilgrastim product that holds the majority of the pegfilgrastim market share.

Coherus Biosciences has announced that the FDA has approved its on-body injector version of Udenyca (pegfilgrastim-cbqv) as biosimilar to Neulasta Onpro (pegfilgrastim with on-body injector).

“Our market studies showed a significant demand for a novel on-body pegfilgrastim delivery device tailored to specific patient needs. We expect that Udenyca Onbody’s 5-minute injection time and innovative retractable needle mechanism will be well received by cancer patients, their caregivers, and doctors,” said Paul Reider, Coherus’ chief commercial officer.

Neulasta Onpro is the pegfilgrastim product that has obtained a majority market share for the pegfilgrastim sector, preventing meaningful uptake, and subsequent savings for pegfilgrastim biosimilars. Patients receiving Udenyca Onbody can have their pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

The news came several months after the FDA approved the autoinjector version of Udenyca in March 2023.

"The on-body injector for Udenyca is the result of years of significant investment in research and development to bring forward a novel and proprietary device that provides patients with an automatic delivery option for their medication,” said Denny Lanfear, CEO of Coherus. “Cancer patients and their physicians will now be able to choose the Udenyca administration presentation that best fits their individual needs: a prefilled syringe, our autoinjector, or this on-body injector.”

The approval was also granted after Coherus received a complete response letter (CRL) in September 2023, which Coherus assured did not raise any issues with the on-body product’s safety or efficacy, saying that the CRL was issued because of an ongoing review at a third-party manufacturing site.

Reference

Coherus announces FDA approval of Udenyca Onbody, a novel and proprietary state-of-the-art delivery system for pegfilgrastim-cbqv. News release. Coherus Biosciences. December 26, 2023. Accessed January 15, 2024. https://investors.coherus.com/news-releases/news-release-details/coherus-announces-fda-approval-udenyca-onbodytm-novel-and

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