After getting approval from the Delhi High Court last week, Zydus Lifesciences introduced its biosimilar of the anti-cancer medication nivolumab in India, priced it significantly less than the patented version.
Zydus Launches Nivolumab Biosimilar in India
The medication, which was introduced under the brand name Tishtha, costs ₹13,950 for a 40-mg dose and ₹28,950 for a 100-mg dose, according to a statement released by the firm on Thursday. It stated that there are more than 500,000 patients using this medication and that “the two-strength portfolio enables physicians to optimize dose and minimize wastage, a critical driver of treatment economics in immunotherapy.”
One of the few targeted immunotherapy medications accessible in India is nivolumab, a monoclonal antibody immunotherapy used to treat a number of advanced malignancies, including lung and head and neck cancers. The medicine, which is sold under the brand name Opdivo and costs between ₹21,500 to more than ₹100,000 for various dosages, is patented in India by the US pharmaceutical company Bristol-Myers Squibb (BMS).
💊 Zydus Nivolumab Biosimilar Launch
- Brand Name: Tishtha
- 40-mg Price: ₹13,950
- 100-mg Price: ₹28,950
- Patient Pool: Over 500,000
- Purpose: Reduce treatment cost and wastage
What Is a Biosimilar?
A biosimilar is a very comparable version of an original biologic that has already been approved and is referred to as the reference product; there are no clinically significant differences in terms of safety, potency, or purity. Biosimilars are not perfect replicas of the original medication, in contrast to generics.
Citing the public interest, a division bench of the Delhi High Court permitted Zydus to promote and sell its nivolumab copycat on January 12. After BMS made a plea, the court changed a single-judge judgment from July 2025 that had prevented the launch.
Delhi High Court Decision and Patent Status
Given that nivolumab is a life-saving cancer medication and that the patent is set to expire on May 2, 2026, the division bench determined that allowing the sale of the biosimilar for the remainder of the patent term was the most practical course of action. In order for BMS to get compensation in the event that it wins the patent infringement lawsuit, the court also ordered Zydus to keep thorough records of its sales during this time.
Nivolumab is a PD-1 checkpoint inhibitor that stops some cancer cells from suppressing the immune system by attaching to and inhibiting the PD-1 protein on their surface. Unlike chemotherapy, which targets both diseased and healthy cells, this enables the immune system to recognize and combat cancer cells.
⚠️ Cancer Immunotherapy Access in India
- Drug Type: PD-1 checkpoint inhibitor
- Used For: Lung, head and neck cancers
- Global Context: Keytruda top-selling drug since 2023
- Main Challenge: Cost and availability
- Impact: Reduced financial burden on patients
Growing Role of Checkpoint Inhibitors
Checkpoint inhibitors have shown promise as a treatment for a number of difficult-to-treat malignancies; since 2023, Keytruda, another PD-1 inhibitor, has been the best-selling medication worldwide.
Although there are a number of checkpoint inhibitors accessible in India, such as Opdivo and Keytruda, availability and cost continue to be major obstacles.
Zydus on Long-Term Availability
For cancer patients who need treatment over several cycles, the consistent availability of checkpoint inhibitors is crucial since disruptions may increase the clinical and financial burden on families. Tishtha, which was created and produced in India, guarantees patients’ long-term reliability during their course of therapy, according to Zydus’ press statement.
Frequently asked questions
1. What is the purpose of nivolumab?
A monoclonal antibody-based immunotherapy medication called nivolumab is used to treat a number of advanced tumors, such as head and neck cancer and lung cancer. It functions by assisting the immune system in identifying and combating cancerous cells.
2. What is the name of Zydus’s nivolumab biosimilar?
In India, Zydus Lifesciences has introduced its nivolumab biosimilar under the Tishtha brand.
3. How much does Tishtha cost in comparison to the original medication Opdivo?
Bristol-Myers Squibb’s Opdivo, which costs between ₹21,500 and over ₹1 lakh depending on dosage, is far more expensive than Tishtha, which costs ₹13,950 for a 40-mg dose and ₹28,950 for a 100-mg dose.
4. In spite of an existing patent, why did the Delhi High Court permit the launch?
Given that nivolumab is a medication that can save lives and that the patent is about to expire on May 2, 2026, the Delhi High Court permitted the launch on the grounds of public interest. In order to potentially compensate BMS, the court also mandated that Zydus keep thorough sales records.
5. What distinguishes generic medications from biosimilars?
Biosimilars are not perfect replicas of the original biologic medication, in contrast to generics. When compared to the reference product, they are quite similar and do not differ in any clinically significant ways in terms of safety, purity, or efficacy.
Conclusion
An important step toward expanding access to cutting-edge cancer immunotherapy in India is the introduction of Zydus Lifesciences’ nivolumab biosimilar Tishtha. Zydus hopes to lower treatment costs and guarantee steady availability for patients who need long-term therapy by producing the medication domestically and delivering it at a deep discount.
The court’s ruling highlights the rising focus on public health requirements, cost, and access to life-saving drugs in India’s healthcare system, even as legal actions surrounding the patent continue.
Disclaimer:
This article is for informational purposes only. It does not constitute medical or legal advice. Drug usage and treatment decisions should be made by qualified healthcare professionals.
