Coherus Receives the US FDA’s Approval of Udenyca (biosimilar, pegfilgrastim) for Febrile Neutropenia
Shots:
- The US FDA has approved a new single-dose prefilled autoinjector presentation of Udenyca, a biosimilar to Neulasta for the treatment and prevention of febrile neutropenia. Udenyca is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation
- The approval was based on the comprehensive analytical data package, along with a PK, PD, and immunogenicity study. The single-dose prefilled autoinjector is expected to be available in Q2’23 and can be used for both in-clinic and at-home administration
- The open-label, crossover study showed PK & PD bioequivalence of Udenyca when administered by the on-body injector through a prefilled syringe
Ref: Globe Newswire | Image: Coherus
Related Post:- Coherus BioSciences Reports the Pooled Analysis of Udenyca (biosimilar, pegfilgrastim) Demonstrated Similar Immunogenicity to Neulasta
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