Zydus Lifesciences Blocked by Delhi High Court in Cancer Biosimilar Case $9.3 Billion Opdyta Patent Dispute Intensifies

Zydus Lifesciences has suffered a major legal setback after the Delhi High Court issued an interim injunction halting further development and commercialization of its biosimilar to Bristol Myers Squibb’s cancer drug Opdyta (nivolumab). The ruling follows a patent infringement suit by BMS, whose blockbuster immunotherapy—known globally as Opdivo—achieved $9.3 billion in global sales in 2024.

The order, delivered July 18, 2025, bans Zydus from manufacturing, selling, importing, or exporting any nivolumab biosimilar while the lawsuit is pending. Justice Mini Pushkarna determined that launching the biosimilar before the patent expires (May 2, 2026 in India) would cause BMS irreparable harm. Zydus had been conducting clinical trials in hopes of an early market launch, and had applied for marketing approval.

Opdyta, a next-generation checkpoint inhibitor, is used to treat cancers such as melanoma, lung, kidney, and Hodgkin lymphoma. Indian patients can access the medicine at discounted rates via company access programs, but the list price remains around ₹200,000 per vial. Indian biosimilars typically cost half as much as their international counterparts.

Zydus, defending with a top legal team, claimed its product (ZRC-3276) did not infringe on BMS’s patents. The case is seen as precedent-setting for other ongoing pharmaceutical patent disputes, including those involving weight-loss and rare-disease drugs. The next hearing is scheduled for August 8.