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Zydus launches cancer biosimilar nivolumab at steep discount

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

Price of the drug launched under the brand name Tishtha 13,950 for the 40 mg dose and The company said in a statement on Thursday that it costs $28,950 for a 100 mg dose. “Two powerful portfolios enable oncologists to optimize dosage and minimize waste, which is a key driver of treatment economics in immunotherapy,” he said, adding that the patient pool for this drug is over 500,000.

Nivolumab is a monoclonal antibody immunotherapy used to treat many 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. 21,500 and above 100,000 for different dosages.

A biosimilar is a highly similar version of the already approved original biological product, known as the reference product, that does not contain clinically meaningful differences in safety, purity and potency. Unlike generic drugs, biosimilars are not exact copies of the original drug.

On January 12, a division bench of the Delhi High Court allowed Zydus to sell and market its nivolumab biosimilar citing public interest. The court changed the single judge decision of July 2025 restricting the launch following an objection by BMS.

Noting that Nivolumab is a life-saving cancer drug and that the patent will expire on May 2, 2026, the division panel decided that the balance of convenience lies in allowing the sale of the biosimilar during the remaining patent term. The court also ordered Zydus to keep detailed records of its sales during this period so that damages could be awarded if BMS is successful in its patent infringement lawsuit.

Improved access

Nivolumab is a PD-1 checkpoint inhibitor that binds to and blocks 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 treatment for many difficult-to-treat cancers; Keytruda, another PD-1 inhibitor, has become the world’s best-selling drug since 2023.

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

“The reliable availability of checkpoint inhibitors is crucial for cancer patients who require treatment over multiple cycles, as disruptions can create both clinical and financial stress for families. Developed and manufactured in India, Tishtha provides patients with long-term reliability throughout their treatment journey,” Zydus said in the statement.

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