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FDA Approves UDENYCA® Autoinjector
- UDENYCA® is the only pegfilgrastim therapy delivered in a convenient, easy-to-administer prefilled autoinjector to offer in-clinic and at-home
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"- UDENYCA® is the only pegfilgrastim therapy delivered in a convenient, easy-to-administer prefilled autoinjector to offer in-clinic and at-home administration options for cancer patients undergoing myelosuppressive chemotherapy - - An additional presentation, the UDENYCA® proprietary on-body injector (OBI) device, is under review by the FDA with anticipated approval this year - REDWOOD CITY, Calif., March 06, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today announced that the U.S. Food and Drug Administration (“FDA”) approved a single-dose, prefilled autoinjector presentation of UDENYCA® (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. The UDENYCA® autoinjector has a streamlined, easy-to-use design for use in both in-office and at-home settings of care. “The introduction of the autoinjector option for UDENYCA®, with the ability to be administered at home or in the doctor’s office, will provide increased choice and control for patients and physicians, ultimately making treatment more accessible to patients,” said Dr. Lee Schwartzberg, Chief of Medical Oncology and Hematology at the Renown Health William N. Pennington Cancer Institute, and Professor of Clinical Medicine, University of Nevada. “There are certain types of cancer patients, those who live far away, have an active lifestyle, or who are supporting the needs of a busy family, for whom this option eliminates the need to return to the clinic and enables them to choose the time and place for treatment without having to wear an on-body device.” “The UDENYCA® autoinjector represents the first innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative solutions that expand access and address the needs of patients undergoing cancer treatment,” said Denny Lanfear, CEO of Coherus. The UDENYCA® autoinjector (AI) is an intuitive design with administration triggered by push-on-skin activation, immediately and reliably delivering a complete pegfilgrastim dose. The approval of UDENYCA® AI was supported by a comprehensive analytical data package, as well as a pharmacokinetic, pharmacodynamic and immunogenicity study.1 Commercial availability of UDENYCA® AI is planned for the second ...