A Delhi High Court verdict on January 12 has allowed Indian pharma company Zydus Lifesciences to manufacture and sell a biosimilar version of Bristol Myers-Squibb's cancer drug Nivolumab. This ruling could pave the way for more affordable immunotherapy treatments for cancer patients in India. Nivolumab is effective against various cancers, with its patent set to expire in May 2026.
The Delhi High Court's decision, issued on January 12, prioritizes public interest amid rising demands for affordable cancer care. Nivolumab, a monoclonal antibody drug, works by boosting the immune system's response to cancer cells, distinguishing it from chemotherapy that affects healthy cells too. It has proven effective against lung, renal, head and neck, melanoma, urothelial, esophageal, and gastric cancers.
In 2024, Bristol Myers-Squibb (BMS) sued Zydus Lifesciences in the Delhi High Court, alleging the Indian firm planned to launch a biosimilar before the patent's expiry in May 2026. A single-judge bench granted an injunction on May 8, 2024, barring Zydus from marketing the product. However, a division bench of Justices C Hari Shankar and Om Prakash Shukla overturned this, citing public interest and the patent's imminent end in about four months.
The bench stated: "Where the product in question is a life-saving drug, the Court has to err in favour of public interest… Withholding such therapy from the public can cause untold and irreparable prejudice to lakhs of lives…"
In India, BMS's branded version, Opdyta, costs between Rs 45,000 and Rs 1 lakh per vial, leading to monthly treatment expenses of Rs 2-3.5 lakh. Zydus's biosimilar, branded Tishtha, is priced at Rs 3.86-6.46 lakh for a full year's treatment—potentially one-third or one-fourth of the current cost. Globally, Nivolumab generated around $9 billion in revenue for BMS in 2023.
