By: IPP Bureau
Last updated : September 15, 2026 5:18 pm
In-house developed and manufactured biosimilar marks company’s entry into immuno-oncology and aims to improve access to checkpoint inhibitor therapy
Dr. Reddy’s Laboratories has launched NIVORZ (nivolumab biosimilar), a biosimilar to Opdivo (nivolumab), in India, marking its entry into the country’s biosimilar immuno-oncology segment.
Developed and manufactured entirely in-house at Dr. Reddy’s biologics facility in Bachupally, Hyderabad, NIVORZ reflects the company’s end-to-end capabilities across the biosimilar value chain, from development to commercialisation.
Oncology remains a key focus area for Dr. Reddy’s, with the launch expanding its oncology portfolio and strengthening its presence in immuno-oncology.
The Indian immuno-oncology market was estimated at approximately Rs. 3,900 crore in 2025 and is predominantly driven by checkpoint inhibitors including nivolumab, pembrolizumab and toripalimab.
The company said NIVORZ is intended to broaden access to nivolumab therapy through a more affordable biosimilar option, addressing the cost and duration of immunotherapy treatment that continue to limit access for many patients.
NIVORZ was evaluated in a multi-country clinical development programme involving 288 patients, including 252 from India and 36 from Russia. The programme demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference nivolumab. The product 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.”
Nivolumab is an immunotherapy agent with a broad range of approved oncology indications in India, spanning metastatic non-small cell lung cancer, renal cell carcinoma, head and neck cancer, melanoma, classical Hodgkin lymphoma, urothelial carcinoma, colorectal cancer, oesophageal cancer, gastric and gastroesophageal junction cancers, malignant pleural mesothelioma and hepatocellular carcinoma.
The approved indications cover early-stage, locally advanced, recurrent and metastatic disease settings across solid and haematological malignancies.