The Delhi High Court has allowed Zydus Lifesciences to sell its biosimilar version of the anti-cancer drug nivolumab in India, delivering a significant win for the pharmaceutical company. A division bench of Justices C. Hari Shankar and Om Prakash Shukla modified an earlier injunction, highlighting public interest and the impending expiration of the patent held by E.R. Squibb & Sons LLC on May 2, 2026.
The court overturned a July 2025 single-judge order that had barred Zydus from launching the biosimilar, emphasizing that nivolumab is a critical life-saving treatment for various cancers. The bench observed that the balance of convenience favored allowing Zydus to market the drug while protecting the innovator’s interests.
To safeguard the patent holder’s rights, the court mandated that Zydus maintain detailed, audited sales records, and submit periodic revenue statements until the patent expires. These measures ensure potential compensation if Squibb’s infringement claim succeeds.
The legal dispute originated when Squibb challenged Zydus in 2024, alleging that the Ahmedabad-based company’s biosimilar, ZRC-3276, was being prepared for launch before patent expiry. Zydus contended that its research and clinical trials fell under the “Bolar exemption” of the Patents Act, which permits the use of patented drugs for regulatory approvals and development of generics.
Nivolumab, a monoclonal antibody immunotherapy, treats cancers such as lung, head, and neck cancers, particularly in cases where chemotherapy is less effective. Current treatment options in India include Opdivo (Squibb), Keytruda (Merck), and Imfinzi (AstraZeneca), with prices ranging from ₹21,500 to over ₹1,00,000 per vial. The introduction of the Zydus biosimilar is expected to enhance affordability and patient access to this critical therapy.
The decision strikes a balance between patent protection and public health access, potentially setting a precedent for biosimilar launches and patent dispute resolution in India’s pharmaceutical sector.
Summary
The Delhi High Court has permitted Zydus Lifesciences to market its nivolumab biosimilar in India before the May 2026 patent expiry of E.R. Squibb & Sons LLC, citing public interest and the drug’s life-saving importance. The ruling requires Zydus to maintain audited sales records and submit revenue reports to safeguard patent-holder rights. Nivolumab treats cancers like lung, head, and neck cancers, and the biosimilar launch is expected to improve accessibility and affordability for patients, while setting an important precedent for biosimilar approvals and patent disputes in India.
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