Zydus launches cancer biosimilar nivolumab at steep discount

MUMBAI: Zydus Lifesciences has launched its biosimilar of anti-cancer drug nivolumab in India after receiving clearance from the Delhi High Court last week, pricing it at a fraction of the patented version.

Launched under the brand name Tishtha, the drug is priced at ₹13,950 for a 40-mg dose and ₹28,950 for a 100-mg dose, the company said in a release on Thursday. “The two-strength portfolio enables oncologists to optimize dosing and minimize wastage, a key driver of treatment economics in immunotherapy,” it said, adding that the patient pool for this drug is over 500,000.

Nivolumab is a monoclonal antibody immunotherapy used to treat several advanced cancers, including lung and head-and-neck cancers, and is among the few targeted immunotherapy drugs available in India. US drugmaker Bristol-Myers Squibb (BMS) holds the patent for the drug in India and sells it under the brand name Opdivo, priced between ₹21,500 and over ₹100,000 for different dosages.

A biosimilar is a highly similar version of an already approved, original biologic, known as the reference product, with no clinically meaningful differences in safety, purity and potency. Unlike generics, biosimilars are not exact copies of the original drug.

On 12 January, a division bench of the Delhi High Court allowed Zydus to sell and market its nivolumab biosimilar, citing public interest. The court modified a July 2025 single-judge order that had restrained the launch following a plea by BMS.

Noting that nivolumab is a life-saving cancer drug and that the patent is due to expire on 2 May 2026, the division bench held that the balance of convenience lay in permitting the biosimilar’s sale for the remaining patent term. The court also directed Zydus to maintain detailed records of its sales during this period so that BMS can be compensated if it ultimately succeeds in the patent infringement suit.

Improved access

Nivolumab is a PD-1 checkpoint inhibitor that works by binding to and blocking the PD-1 protein on the surface of some cancer cells, preventing them from suppressing the body’s immune system. This allows the immune system to identify and attack cancer cells, unlike chemotherapy, which attacks both cancerous and healthy cells.

Checkpoint inhibitors have emerged as a promising therapy for several hard-to-treat cancers, with Keytruda, another PD-1 inhibitor, becoming the world’s top-selling drug since 2023.

While several checkpoint inhibitors, including Opdivo and Keytruda, are available in India, pricing and access remain key challenges.

“Reliable availability of checkpoint inhibitors is essential for cancer patients who require therapy over multiple cycles, as interruptions may add both clinical and financial stress for families. Developed and manufactured in India, Tishtha ensures long-term dependability for patients throughout their treatment journey,” Zydus said in the release.