FDA approval of Udenyca Onbody,(pegfilgrastim-cbqv) a novel and proprietary state-of- the-art delivery system for management of febrile neutropenia.- Coherus BioSciences Inc.
Coherus BioSciences, Inc., announced that the 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.”
Commercial availability of Udenyca Onbody is planned for the first quarter of 2024.
“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.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins