During a presentation on 15 September 2026, Amgen confirmed that it has filed an abbreviated Biologics License Application (aBLA) with the FDA for a biosimilar to Bristol Myers Squibb/Ono Pharmaceutical’s Opdivo® (nivolumab). The aBLA has been accepted for review. This is the first publicly disclosed aBLA to have been filed and accepted in the US in relation to biosimilar nivolumab. Amgen is expecting an FDA decision in relation to its nivolumab biosimilar, ABP 206, by year end.
As a result of the FDA filing, BMS and Ono commenced BPCIA litigation against Amgen in relation to ABP 206 on 14 September 2026. In their complaint filed in in the US District Court for the District of Delaware, BMS/Ono allege that Amgen infringes 7 US patents in relation to nivolumab and methods of treatment using nivolumab (US Patent Numbers 8,008,449, 9,856,320, 10,072,082, 12,590,154, 12,624,107, 12,590,153, and 12,479,917).
BMS and Ono are seeking remedies including a preliminary and/or permanent injunction to restrain Amgen from infringement the asserted patents, including by manufacturing or selling biosimilar nivolumab in the US while the patents remain in force.
The US litigation is not the first to be fought around the world in relation to nivolumab biosimilars. In January 2026, the High Court of Delhi reversed on appeal a preliminary injunction granted to BMS in relation to Zydus’ biosimilar, Tishtha™ (approved July 2024).
BMS’ patent rights for nivolumab are being challenged including in the EU where EP 3 288 980, for a composition comprising nivolumab for use in a method of treating PD-L1-positive melanoma, was revoked in July 2026 following an opposition by 5 “strawperson” opponents.
A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, and Shilpa’s intravenous nivolumab biosimilar.