On 11 February 2026, the Supreme Court of India dismissed the Special Leave Petition of BMS requesting an appeal from the decision of the High Court of Delhi appellate division that allowed Zydus to launch its low cost nivolumab biosimilar, Tishtha®, pending resolution of the infringement claim brought by BMS. The Supreme Court has also ordered Zydus to provide a sample of its product to BMS for mapping against its patent claims.
Zydus launched Tishtha® in India on 22 January 2026, just over a week after the first instance 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’ Court loss will be encouraging to 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.