Dr. Reddy’s Laboratories on Tuesday said it is foraying into the biosimilar immuno-oncology therapy segment in India with the launch of Nivorz, a biosimilar of Bristol Myers Squibb’s Opdivo (nivolumab).
The biosimilar has been developed and manufactured entirely in-house at its biologics facility in Bachupally, Hyderabad. The launch reflects the company’s end-to-end capabilities across the biosimilar value chain, from development through commercialisation, Dr. Reddy’s said.
In 2025, the immuno-oncology market in India was estimated to be around ₹3,900 crore and predominantly driven by checkpoint inhibitors such as nivolumab, pembrolizumab and toripalimab, it said.
“The launch of Nivorz strengthens our oncology portfolio and expands 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,” CEO Global Generics M.V. Ramana said.
The company said 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, it has been approved in India by the Drugs Controller General of India (DCGI).
Global Head of Biologics at Dr. Reddy’s Sridevi Khambhampaty said “the launch of Nivorz marks an important milestone for the company’s biologics business. It reinforces our commitment to expanding patient access to high-quality and reflects our continued focus on developing complex biosimilars.”
Nivorz is one of the immunotherapy agents with the broadest range of approved indications in oncology in India. The approved indications span early-stage, locally advanced, recurrent and metastatic disease settings across both solid and hematological malignancies, the company said.
Published – September 15, 2026 09:33 pm IST
