Zydus Faces Legal Setback in Cancer Biosimilar Ambitions

Zydus Lifesciences’ push to launch a biosimilar version of the cancer drug nivolumab (Opdyta, globally known as Opdivo) has hit a serious hurdle after the Delhi High Court issued an interim injunction restraining the company from any activity related to the biosimilar, including manufacturing, sales, imports, or exports. This legal block, initiated by Bristol Myers Squibb’s patent infringement suit, follows Zydus’ ongoing clinical trials in India for its proposed biosimilar ZRC-3276. The patent for nivolumab in India is valid until May 2, 2026. The court’s order, delivered on July 18, 2025, restricts Zydus until the case’s next hearing on August 8, highlighting that Bristol Myers could suffer irreparable loss if relief was not granted. This setback carries significant implications for Zydus shareholders. On one hand, developing biosimilars for blockbuster cancer drugs presents a lucrative opportunity. Opdyta is among the most advanced immunotherapies, heavily used for treating various cancers and generating over $9 billion in global sales annually for Bristol Myers. Indian biosimilars are typically offered at half the price of global drugs, promising access and volume if patent barriers are cleared. However, the injunction delays launch plans, halts market entry, and means deferral of potential revenues. The ruling also underscores legal risks for Zydus in its biosimilar strategy, raising concerns among investors regarding the company’s pipeline execution, especially for complex biotech products. Indian patent law experts note the court’s strict view on stockpiling during patent validity, which could affect other biosimilar ventures. For Zydus shareholders, the immediate consequence is negative—loss of revenue opportunity and prolonged regulatory uncertainty with possible market repercussions. The resolution and eventual patent expiry may revive prospects, but short-term sentiment and stock performance are likely to be impacted.