CHENNAI: A division bench of the Delhi High Court on Monday allowed Indian drugmaker Zydus Lifesciences to sell and market its biosimilar version of the anti-cancer drug nivolumab in the domestic market, citing public interest and the need to improve patient access to life-saving medicines.
The court revised a July 2025 order by a single judge that had blocked Zydus' launch following a plea by innovator and patent holder of the biological drug -- E.R. Squibb & Sons LLC, which markets the drug as Opdivo.
In its order, the court said that permitting the biosimilar to be marketed would help make the expensive cancer therapy more affordable and widely available, while also serving the broader public interest. Nivolumab, an immunotherapy used in the treatment of several types of cancer, is considered a critical drug but remains out of reach for many patients because of its high cost.
The ruling came in a case involving patent and regulatory disputes over the launch of the biosimilar. The drugmaker had sought permission to proceed with sales, arguing that it had met the required regulatory standards and that blocking its product would limit access to treatment for a large number of patients.
The bench weighed the commercial interests of the innovator company against the potential public health impact and concluded that patient welfare and access to affordable medicine must take priority. It noted that allowing competition through biosimilars could significantly reduce treatment costs and ease the financial burden on patients and healthcare systems.
The decision clears the way for the drugmaker to introduce its nivolumab biosimilar in the Indian market, potentially increasing availability of the therapy and intensifying competition in the oncology segment. The case is also seen as an important precedent in how courts balance intellectual property rights with public health considerations in the pharmaceutical sector.