Coherus receives FDA approval for UDENYCA ONBODY on-body injector

Coherus Oncology, Inc.

FDA approved UDENYCA ONBODY on December 26, 2023, a pegfilgrastim biosimilar to reduce febrile neutropenia after chemotherapy.
Product includes indicator light, auditive signal, and automatic needle retraction to confirm dose and reduce needlestick risk.
Commercial launch planned for Q1 2024.
Approval supported by pharmacokinetic/pharmacodynamic bioequivalence and adhesive performance data.

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