Dr. Reddy’s Laboratories has launched Nivorz, a biosimilar of Bristol Myers Squibb’s Opdivo (nivolumab), entering India’s biosimilar immuno-oncology market. The drug was developed and manufactured at the company’s biologics facility in Bachupally, Hyderabad, showcasing its complete capabilities in biosimilar development and commercialisation.
India’s immuno-oncology market, estimated at ₹3,900 crore in 2025, is driven mainly by checkpoint inhibitors like nivolumab, pembrolizumab, and toripalimab. Nivorz aims to improve access to affordable, high-quality immunotherapy options in this expanding cancer-treatment segment.
The biosimilar underwent a multi-country clinical programme involving 288 patients — 252 from India and 36 from Russia, proving comparable efficacy, safety, pharmacokinetics, and immunogenicity to reference nivolumab. Following this, it received approval from the Drugs Controller General of India (DCGI).
Dr. Reddy’s highlighted that Nivorz has one of the broadest ranges of approved oncology indications among immunotherapies in India, covering early-stage, locally advanced, recurrent, and metastatic diseases in both solid and hematological malignancies. This launch enhances the company’s oncology portfolio and supports its mission to expand patient access to complex biosimilar therapies.
