BMS has applied to the Supreme Court of India for leave to appeal against the 12 January 2026 decision of the High Court of Delhi appellate division, which allowed Zydus to launch Tishtha®, biosimilar to BMS’ Opdivo®/Opdyta®, in India pending resolution of the patent infringement claim brought by BMS. The petition for leave to appeal was listed by the Supreme Court of India on 29 January 2026. A hearing is scheduled for 4 February 2026.
In overturning a preliminary injunction granted in July 2025 preventing launch of Tishtha®, the High Court appellate division put significant weight on the public interest in having access to lower cost, life-saving drugs and held that BMS’s interests could be preserved by Zydus providing accounts of its sales. Presumably, if granted leave to appeal, BMS will ask the Supreme Court to revisit this balancing of interests.
Zydus launched Tishtha® in India on 22 January 2026, just over a week after the High Court decision. The biosimilar had received regulatory approval in India in July 2024 and is the first nivolumab biosimilar in the world to reach the market. In India, Tishtha® is priced at about one quarter the cost of BMS’ Opdivo®/Opdyta®.
BMS’ appeal will be closely watched by other companies with nivolumab biosimilars in the pipeline aimed at the Indian market, such as Enzene and Reliance Life Sciences. Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius and Biocon also have nivolumab biosimilars under development.