Coherus Announces FDA Approval of UDENYCA ONBODY, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv

– Innovative design enables five-minute pegfilgrastim delivery time –

– Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving pegfilgrastim –

REDWOOD CITY, Calif., Dec. 26, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) approved UDENYCA ONBODY, the company's on-body injector (OBI) presentation of UDENYCA (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

“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.”

“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 five-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.

“Our state-of-the-art UDENYCA ONBODY device is unlike other approaches in that it is not adapted or repurposed from other medical uses,” said Rich Hameister, Coherus’ Chief Technical Officer. “This is a clean sheet, grounds-up, de novo approach designed for pegfilgrastim administration that applies proprietary technology and user insights to produce a reliable and highly intuitive patient experience.”

UDENYCA ONBODY was designed with patients in mind; key features include an indicator and status light and auditive signal that help patients confirm the dose has been administered and a strong and well-tolerated adhesive. After the dose is administered, the needle automatically retracts, which reduces the risk of needlestick injury.

The approval of UDENYCA ONBODY was supported by a comprehensive analytical and clinical data package, including pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence data as well as adhesive performance and tolerability data.