Pharma Focus Asia

Coherus BioSciences Announces US FDA Approval of UDENYCA® Autoinjector

Tuesday, March 07, 2023

Coherus BioSciences 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.

UDENYCA® autoinjector (AI) 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.

The UDENYCA® AI is an intuitive design with administration triggered by push-on-skin activation, immediately and reliably delivering a complete pegfilgrastim dose. 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.

UDENYCA® AI is the only pegfilgrastim brand offering two on-demand options—prefilled syringe (PFS) and AI providing more choice and flexibility customised to meet the needs of patients and practises. UDENYCA® (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device is under review by the FDA. If approved, UDENYCA® OBI will offer providers a highly desired alternative to the originator’s on-body pegfilgrastim delivery system.

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