On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of Bristol Myers Squibb’s US patents relating to methods of treatment using nivolumab and ipilimumab for cancer generally (US 9856320), melanoma (US 10174113) and colorectal cancer (US 11332529).
Amgen currently has a biosimilar to BMS’ Opdivo® (nivolumab) under development, having enrolled patients in a Phase 3 study evaluating the efficacy, safety, and immunogenicity of Amgen’s ABP 206 compared with Opidvo®. The study is expected to be completed in 2027.
BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) combination has been approved in Europe for certain colorectal cancer patients (December 2024) and is under evaluation for the same indication in the US (sBLA accepted in February 2025), Australia (TGA application filed in July 2024) and Japan (supplemental application filed in September 2024). The combination therapy is also being considered for treatment of hepatocellular carcinoma including in the US. Expansion of approval to this indication in Europe was recommended in January 2025.