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UK’s MHRA Approves BMS’ SC Opdivo® (Nivolumab)

Apr 30, 2025

On 30 April 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved a subcutaneous (SC) formulation of BMS’ Opdivo® (nivolumab).  The SC formulation of nivolumab can be given as a 3–5 minute injection instead of the 30 or 60 minute intravenous (IV) infusion.

Amgen currently has a nivolumab biosimilar under development, having enrolled patients in a Phase 3 study evaluating the efficacy, safety, and immunogenicity of Amgen’s ABP 206 compared with Opdivo®.  The study is expected to be completed in 2027.

Sandoz is also developing a biosimilar of nivolumab and is recruiting patients for an integrated Phase I/III trial in the advanced melanoma setting.