Delhi High Court allows Zydus to sell cheaper biosimilar of cancer drug Nivolumab in public interest

The decision is expected to significantly improve affordability and access, as the Zydus biosimilar is priced nearly 70 per cent lower than the patented therapy

• Delhi HC permits Zydus to sell cheaper Nivolumab biosimilar.
• Zydus biosimilar costs 70% less than Bristol Myers Squibb's therapy.
• Court orders Zydus to keep sales records until BMS patent expires in May 2026

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In a move described as being driven by public interest, the Delhi High Court has permitted Zydus Lifesciences to manufacture and sell a biosimilar version of Bristol Myers Squibb's blockbuster cancer drug Nivolumab, The Times of India reported. The decision is expected to significantly improve affordability and access, as the Zydus biosimilar is priced nearly 70 per cent lower than the patented therapy.

A division bench comprising Justices C Hari Shankar and Om Prakash Shukla on Monday overturned an earlier single-judge ruling that had restrained Zydus from launching its product. The court observed that when the drug involved is life-saving in nature, judicial decisions must lean in favour of public interest, while ensuring that the innovator's rights are safeguarded through appropriate mechanisms, The Times of India said.

The earlier single-bench order had barred Zydus from marketing its biosimilar, ZRC 3276, on the grounds that it infringed the patent held by Bristol Myers Squibb. The drug is used in the treatment of several life-threatening cancers. The latest ruling comes just four months ahead of the expiry of BMS' patent on Nivolumab, sold under the brand name Opdiva, which is due to lapse on May 2, 2026.

In its order, accessed by The Times of India, the court said that instead of denying patients access to a critical therapy, the balance of convenience lay in allowing Zydus to sell the drug while maintaining detailed accounts of revenues generated until the patent expires. The bench directed the company to preserve sales records during this period.

The judges acknowledged the delicate balance courts must strike between protecting public health and upholding intellectual property rights. Quoting from the order, The Times of India reported the bench as saying courts are required to walk a "tightrope" in such matters, keeping in mind their duty to citizens who may be in urgent need of life-saving treatment.

At the same time, the court cautioned against undermining patent protection, noting that unchecked infringement of pharmaceutical patents could erode incentives for innovation. Allowing widespread circulation of drugs that violate valid patents could discourage future investment in research and development, ultimately harming the pipeline of new and effective therapies, the order noted, as reported by The Times of India.