Coherus BioSciences, a biopharmaceutical company in the commercial stage, has received approval from the U.S. Food and Drug Administration (FDA) for its UDENYCA ONBODY. This is an on-body injector presentation of UDENYCA, a biosimilar of pegfilgrastim used to reduce the incidence of infection, specifically febrile neutropenia, in patients with non-myeloid malignancies undergoing myelosuppressive anti-cancer treatment.
The FDA approval marks a significant milestone for Coherus BioSciences. UDENYCA ONBODY is an innovative device developed through extensive research and development efforts, providing patients with an automatic delivery option for their medication. Unlike other approaches, this on-body injector is not repurposed from other medical uses; instead, it represents a ground-up, de novo design specifically for pegfilgrastim administration. The device incorporates proprietary technology and user insights to offer a reliable and intuitive patient experience.
Patient-centric design is a key focus, with features such as an indicator and status light, auditive signal for dose confirmation, and a robust and well-tolerated adhesive. Importantly, the needle automatically retracts after the dose is administered, minimizing the risk of needlestick injury.
The approval was supported by a comprehensive data package encompassing analytical and clinical data, including pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence data, as well as data on adhesive performance and tolerability.
UDENYCA, the medication delivered by the on-body injector, is indicated not only to decrease the incidence of infection in certain cancer patients but also to increase survival in individuals acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). This development signifies a commitment to advancing drug delivery technology and enhancing the overall experience for patients undergoing cancer treatment.
