The Food and Drug Administration (FDA) has approved a new single-dose prefilled autoinjector presentation of Udenyca® (pegfilgrastim-cbqv), a biosimilar to Neulasta.
Udenyca is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
According to Coherus, the approval of the prefilled autoinjector was supported by a comprehensive analytical data package, along with a pharmacokinetic, pharmacodynamic and immunogenicity study. The single-dose prefilled autoinjector is expected to be available in the second quarter of 2023 and can be used for both in-clinic and at-home administration.
The Company is also anticipating approval of Udenyca delivered via an on-body injector device this year. Data from an open-label, crossover study showed pharmacokinetic and pharmacodynamic bioequivalence of Udenyca when administered by the on-body injector vs a prefilled syringe.
FDA approves Udenyca® autoinjector. News release. Coherus BioSciences, Inc. Accessed March 6, 2023. https://www.globenewswire.com/news-release/2023/03/06/2621056/33333/en/FDA-Approves-UDENYCA-Autoinjector.html.