FDA Approves Delivery System of Biosimiliar Pegfilgrastim-cbqv for Febrile Neutropenia

FDA

The FDA has approved an on-body injector (OBI) presentation of the biosimilar pegfilgrastim-cbqv biosimilar (Udencya), known as Udencya Onbody, which is administered to patients with cancer the day after chemotherapy in order to decrease infection incidence from febrile neutropenia.¹

The decision for the approval was supported by a comprehensive analytical and clinical data package, including data on pharmacokinetics and pharmacodynamics bioequivalence, plus findings on adhesive performance and tolerability. Coherus BioSciences, the developer of the biosimilar, stated in a news release that commercial availability of Udencya Onbody is planned for the first quarter of 2024.

“The on-body injector for Udencya 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,” Denny Lanfear, CEO of Coherus, said in a news release. “Cancer patients and their physicians will now be able to choose the Udencya administration presentation that best fits their individual needs: a prefilled syringe, our autoinjector, or this on-body injector.”

Udencya Onbody UDENYCA comprises an indicator, status light, and auditive signal that help patients confirm the administration of their chemotherapy dose; it also includes an adhesive. After the dose is administered, the needle automatically retracts, which Coherus stated reduces needlestick injury risk.

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

In March 2023, the FDA approved a single-dose, prefilled autoinjector presentation of pegfilgrastim-cbqv to be given the day after chemotherapy to reduce the incidence of infection as manifested by febrile neutropenia.²

The biosimilar is a leukocyte growth factor that is indicated to reduce the incidence of infection in those with non-myeloid cancers who are receiving myelosuppressive agents linked with a significance incidence of febrile neutropenia. The agent is also indicated to improve survival in those who are acutely exposed to myelosuppressive doses of radiation.

References

1. Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv. Coherus Biosciences. December 26, 2023. Accessed December 26, 2023. https://investors.coherus.com/news-releases/news-release-details/coherus-announces-fda-approval-udenyca-onbodytm-novel-and
2. FDA approves Udenyca autoinjector. News release. Coherus BioSciences, Inc. March 6, 2023. Accessed March 6, 2023. https://investors.coherus.com/news-releases/news-release-details/fda-approves-udenycar-autoinjector