Dr. Reddy’s Laboratories launches NIVORZ in India
Developed entirely in-house through Dr. Reddy's end-to-end biosimilar development and manufacturing capabilities
Dr. Reddy’s Laboratories announced the launch of NIVORZ (Nivolumab Biosimilar) in India. NIVORZ is a biosimilar to Opdivo(nivolumab).
The launch represents a significant milestone for Dr. Reddy’s, with NIVORZ marking its entry into biosimilar immuno-oncology in India. Developed and manufactured entirely in-house at Dr. Reddy’s biologics facility in Bachupally, Hyderabad, it reflects the company’s end-to-end capabilities across the biosimilar value chain, from development through commercialization.
Oncology remains an important focus area for Dr. Reddy’s. The launch of NIVORZ further strengthens the company’s oncology portfolio and expands its presence in immuno-oncology. The Immuno-Oncology market in India is estimated at approximately ₹3,900 crore in 2025 and is predominantly driven by checkpoint inhibitors such as nivolumab, pembrolizumab and toripalimab.
Access to immuno-oncology therapies remains a challenge for many patients due to the cost and duration of treatment. Through NIVORZ, Dr. Reddy’s aims to broaden access to high-quality nivolumab therapy with an affordable biosimilar option for eligible patients.
NIVORZ was evaluated through a multi-country clinical development programme involving 288 patients, including 252 from India and 36 from Russia, and demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference nivolumab. Based on this clinical development programme, NIVORZ has been approved in India by the Drugs Controller General of India (DCGI).
Dr. Sridevi Khambhampaty, Global Head of Biologics, Dr. Reddy’s Laboratories, said: “The launch of NIVORZ marks an important milestone for our biologics business. It reinforces our commitment to expanding patient access to high-quality biologic therapies, strengthens our oncology portfolio and reflects our continued focus on developing complex biosimilars.”
M.V. Ramana, CEO Global Generics, Dr. Reddy’s Laboratories, said: “The launch of NIVORZ strengthens our oncology portfolio and expands our presence in immuno-oncology. As access to immunotherapy continues to be a challenge for many patients, we remain committed to improving access to high-quality treatment options through affordable biosimilars such as NIVORZ.”