India Pharma Outlook Team | Wednesday, 16 September 2026
Dr. Reddy’s Laboratories enters India’s nivolumab race and intensifies competition that can cut cancer drug prices for patients.
The Hyderabad-based company launches Nivorz, its biosimilar to Bristol Myers Squibb’s blockbuster immunotherapy, and expands access in a market long dominated by high-cost innovator products.
This move strengthens the firm’s oncology portfolio and challenges existing players in immuno-oncology.
Patients facing limited options for multiple cancer types now gain another biosimilar alternative. The launch underscores how Indian manufacturers drive affordability and broader treatment reach in a segment valued at thousands of crores.
Dr. Reddy’s Laboratories announces the commercial launch of Nivorz, a biosimilar alternative to nivolumab, in India. The company ends Zydus Lifesciences’ free run as the sole biosimilar provider and marks its entry into the country’s immuno-oncology market.
The firm manufactures Nivorz at its Bachupally biologics facility in Hyderabad. It markets the product in single-dose vial presentations of 40 mg, 100 mg and 240 mg strengths.
The Drugs Controller General of India approved the biosimilar after a multi-country clinical trial involving 288 patients, 252 from India and 36 from Russia. The study demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug.
Key features of the launch include:
Nivolumab acts as a fully human monoclonal antibody that blocks the PD-1 receptor on T-cells and helps the immune system mount a stronger response against tumors. Opdivo, the innovator brand, generated over USD 10 billion in sales in 2025 across more than 65 countries.
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India’s immuno-oncology market stands at around Rs 3,900 crore, with nivolumab, pembrolizumab and toripalimab commanding the major share. Access remains a challenge for many patients because of the cost and duration of treatment.
Zydus Lifesciences launched the first biosimilar, Tishtha, in January this year after a legal battle with the innovator. That brand is available in 100 mg and 40 mg strengths at Rs 28,950 and Rs 13,950, respectively, which the company claims equals about one-fourth of the innovator’s price. Dr. Reddy’s does not disclose its own market price for Nivorz.
Company executives highlight the access goal. M.V. Ramana, CEO of Global Generics at Dr. Reddy’s, states that the launch strengthens the oncology portfolio and expands presence in immuno-oncology as access to immunotherapy continues to challenge many patients.
Sridevi Khambhampaty, global head of biologics, calls the launch an important milestone that expands patient access to biologic therapies and supports the focus on complex biosimilars.
Dr. Reddy’s entry increases competition in the nivolumab segment and gives oncologists and patients another treatment option across a wide range of cancers. The biosimilar route aims to ease affordability pressures that previously limited uptake of checkpoint inhibitors.
The launch also reflects India’s growing capability in complex biologics manufacturing. Both Zydus and Dr. Reddy’s now supply biosimilar nivolumab, which can intensify price competition and further improve access over time. Shares of Dr. Reddy’s closed at Rs 1,149 on the day of the announcement, down 1.42 percent from the previous close.
This development adds momentum to India’s biosimilar immuno-oncology space and places greater emphasis on making advanced cancer therapies available to a larger patient population.