Bristol Myers Approaches SC to Halt Zydus' Biosimilar Nivolumab Sale

Published On 2026-01-30 14:05 GMT | Update On 2026-01-30 14:05 GMT

New Delhi: Bristol Myers Squibb has approached the Supreme Court of India, seeking to restrain Zydus Lifesciences from manufacturing and selling its biosimilar version of the cancer drug nivolumab, escalating the legal battle over patent rights and market exclusivity in the Indian oncology drug space.

In its plea before the apex court, Bristol Myers Squibb has argued that Zydus’s biosimilar infringes upon its intellectual property related to nivolumab, a monoclonal antibody used extensively in the treatment of multiple cancers. The US-based drugmaker has sought an interim order to halt the production and commercial sale of the biosimilar until the dispute over patent protection and exclusivity is finally adjudicated.

The legal challenge follows an earlier decision by the Delhi High Court, which allowed Zydus to proceed with the sale of its biosimilar nivolumab product. The high court ruling was seen as a significant development in favour of expanding access to more affordable cancer therapies, particularly for patients dependent on high-cost biologic medicines.

Also Read: Bristol Myers Squibb, SystImmune gets USFDA Breakthrough Therapy Designation for izalontamab brengitecan for previously treated Advanced EGFR Mutated Non Small Cell Lung Cancer

Zydus has maintained that the relevant patent protections for Bristol Myers Squibb’s original nivolumab product have either expired or are no longer enforceable in India, thereby permitting the launch of its biosimilar. The company has positioned its product as a lower-cost alternative aimed at improving patient access to life-saving oncology treatments.

The Supreme Court is expected to examine the matter in the coming days, with its decision likely to have a bearing on the future of biosimilar competition and patent enforcement in India’s rapidly evolving biopharmaceutical market, reports The Economic Times.

Also Read: Zydus Completes Agenus Deal, Launches US-Based Biologics CDMO Arm Zylidac Bio

Article Source : with inputs

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Parthika Patel

Parthika Patel has completed her Graduated B.Pharm from SSR COLLEGE OF PHARMACY and done M.Pharm in Pharmaceutics. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

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Bristol Myers Approaches SC to Halt Zydus' Biosimilar Nivolumab Sale

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