Pune, India | January 13, 2026
The Delhi High Court allowed Zydus Lifesciences to sell its Zydus nivolumab biosimilar, marking a landmark step for patient access in India. The bench overturned a previous interim order and emphasized affordable cancer care as the patent nears expiry. Consequently, this decision expands treatment options while balancing intellectual property protection.
The ruling arose from a patent dispute between Zydus and E.R. Squibb & Sons LLC (also Bristol Myers Squibb), the developer of nivolumab. This monoclonal antibody immunotherapy enhances the immune system’s ability to attack cancer cells, particularly in lung, head, and neck cancers. While Opdivo remains expensive, the Zydus nivolumab biosimilar offers a lower-cost option, increasing access for many patients.
Earlier, in July 2025, a single judge issued an interim injunction preventing Zydus from selling the Zydus nivolumab biosimilar during Squibb’s patent term. Squibb claimed that Zydus conducted early trials and was prepared to launch the biosimilar prematurely. However, the division bench found insufficient evidence to justify the injunction and modified the previous order.
The court balanced patent protection against patient needs, noting the high costs of cancer treatment. Allowing the Zydus nivolumab biosimilar could significantly reduce expenses for patients and healthcare providers. Analysts predict this decision will increase competition in oncology markets, possibly driving overall price reductions.
To protect both parties, the High Court directed Zydus to maintain detailed, independently audited records of all sales and revenues from the Zydus nivolumab biosimilar until patent expiry. These records must be submitted periodically, enabling Squibb to claim compensation if it prevails in the patent dispute. This provision allows Zydus to launch the product while respecting the innovator’s rights.
The Zydus nivolumab biosimilar may enter the market before the patent expires. The court ruled that withholding access to a life-saving drug would cause unnecessary hardship. As a result, patients may benefit from earlier availability of affordable therapy.
Healthcare advocates welcomed the ruling, highlighting India’s rising cancer burden. High costs often prevent timely or complete treatment, particularly in low- and middle-income communities. The introduction of the Zydus nivolumab biosimilar could provide many patients access to effective treatment, bridging affordability gaps across the country.
Pharmaceutical experts consider the ruling precedent-setting for future biosimilar disputes in India. Courts have increasingly balanced intellectual property rights with public health priorities, especially for critical oncology drugs. This decision signals a progressive approach to biosimilar approvals in markets where access is essential.
The dispute began when Squibb alleged that Zydus acted to commercially launch its biosimilar before patent expiry. Zydus countered that its product met all regulatory requirements and did not infringe the patent. Additionally, Zydus highlighted ongoing proceedings challenging the patent’s validity, which supported its defense and influenced the ruling.
With the injunction lifted, Zydus can now manufacture and distribute the Zydus nivolumab biosimilar across India. The company has already obtained the regulatory approvals required for market introduction. This quick shift from legal restraint to clearance demonstrates the dynamic nature of India’s pharmaceutical sector.
Critics of the previous injunction argued that limiting biosimilar launches near patent expiry restricts access to essential medicines. By modifying the earlier order, the High Court reinforced the importance of affordable therapeutic options, patient welfare, and competition in oncology treatment.
In the coming months, Zydus plans to roll out the Zydus nivolumab biosimilar nationwide. Observers anticipate increased competition among cancer drug providers, which could influence pricing and availability. The pharmaceutical industry will closely monitor this case for future biosimilar strategies and patent challenges.
Overall, the Delhi High Court’s decision represents a milestone in India’s healthcare and legal landscape. By permitting the Zydus nivolumab biosimilar, the ruling balances commercial rights with public access. As patients receive this treatment, its impact on affordability, treatment outcomes, and nationwide access will become evident.
