**Zydus Lifesciences Secures Approval to Market Nivolumab Biosimilar in India**
In a significant development for Zydus Lifesciences, the Delhi High Court has granted the drug manufacturer permission to sell and market its biosimilar version of the anti-cancer drug nivolumab in India, emphasizing the importance of public interest. This ruling modifies a previous order from July 2025, which had prohibited the launch due to a request from E.R. Squibb & Sons LLC, the patent holder of the original drug marketed as Opdivo.
The bench, comprising Justices C. Hari Shankar and Om Prakash Shukla, noted that Squibb’s patent is set to expire on May 2, 2026. The court allowed Zydus to proceed with sales while mandating the company to maintain comprehensive and audited sales records. This measure ensures that if Squibb ultimately prevails in its patent infringement lawsuit, it can be compensated accordingly.
During the verbal announcement, the court expressed its inability to agree with the earlier decision that completely barred Zydus from launching its product. The judges highlighted the critical nature of nivolumab as a life-saving cancer treatment and acknowledged the approaching expiration of the patent. They concluded that the balance of convenience favored allowing the biosimilar’s sale while still protecting the interests of the patent holder.
A detailed written judgment is expected soon. Nivolumab, a monoclonal antibody immunotherapy, is utilized in treating various cancers, including lung and head and neck cancers, particularly in cases where chemotherapy is less effective. The drug’s significance is underscored by the rising cancer incidence in India.
In addition to nivolumab, other immunotherapy options like Merck’s pembrolizumab (Keytruda) and AstraZeneca’s durvalumab (Imfinzi) are also available in the Indian market. However, the high cost of these therapies remains a concern for many patients. The price of nivolumab can range from ₹21,500 to over ₹1,00,000, depending on dosage and supplier.
The legal dispute began in 2024 when E.R. Squibb & Sons LLC filed a case against Zydus Lifesciences, alleging that the company was preparing to launch a biosimilar version of nivolumab before the expiration of its Indian patent in May 2026. Squibb holds a patent for the monoclonal antibody used in cancer treatment and claimed that Zydus had developed a biosimilar, sought regulatory approvals, conducted clinical trials, and identified nivolumab as the reference biologic, indicating an imminent commercial launch.
As the situation develops, the implications for both companies and cancer patients in India will be closely monitored.
**FAQ**
**What is nivolumab and why is it important?**
Nivolumab is a monoclonal antibody used in immunotherapy to treat various cancers. It is crucial for patients, especially when other treatments are ineffective, and its availability as a biosimilar may improve access and affordability for many.