In a significant development for India's pharmaceutical sector and cancer patients, a division bench of the Delhi High Court on Monday, January 12, 2026, permitted Zydus Lifesciences to manufacture and sell its biosimilar version of Nivolumab, an anti-cancer drug patented by US pharmaceutical major Bristol Myers Squibb (BMS). This ruling overturns an earlier interim injunction issued by a single judge on July 18, 2025, which had temporarily restrained Zydus from launching its biosimilar (ZRC-3276) until the expiration of BMS's patent in India on May 2, 2026. The earlier injunction was granted based on BMS's claims of patent infringement, arguing that Zydus was preparing for a commercial launch of its biosimilar during the life of a valid patent. However, Zydus had disputed these claims, stating its product did not infringe the patent and complied with regulatory frameworks. The division bench, comprising Justices C. Hari Shankar and Om Prakash Shukla, emphasized public interest and the need for access to affordable treatment, noting that "The ailing public cannot be deprived of Zydus' drug." A key factor in the court's decision was the imminent expiry of BMS's Indian patent for Nivolumab (marketed globally as Opdivo and in India as Opdyta) on May 2, 2026. While allowing Zydus to proceed, the court directed the company to maintain detailed and audited records of its sales until the patent lapses. This is to ensure that BMS can be compensated if it ultimately succeeds in its patent infringement suit. Nivolumab is a crucial immunotherapy drug used to treat various cancers, including lung, kidney, and head and neck cancers, and its availability as an affordable biosimilar is expected to significantly benefit Indian patients.