Dr Reddy’s launches nivolumab biosimilar in India
Hyderabad, Sept 15 (TNT): Dr Reddy’s Laboratories on Tuesday announced the launch of NIVORZ, a biosimilar of nivolumab, in India, marking its entry into the biosimilar immuno-oncology segment.
NIVORZ is a biosimilar to Opdivo (nivolumab) and has been developed and manufactured at Dr Reddy’s biologics facility in Bachupally, Hyderabad, the pharma giant said in a release.
The launch expands Dr Reddy’s oncology portfolio and its presence in immuno-oncology.
The company said the Indian immuno-oncology market was estimated at around Rs 3,900 crore in 2025 and is primarily driven by checkpoint inhibitors, including nivolumab, pembrolizumab and toripalimab.
The company said NIVORZ is intended to provide an affordable biosimilar option for eligible patients requiring nivolumab therapy.
NIVORZ was evaluated in a multi-country clinical development programme involving 288 patients, including 252 from India and 36 from Russia. According to the company, the study demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity with reference nivolumab.
The biosimilar has been approved in India by the Drugs Controller General of India (DCGI), the company said.
Dr Sridevi Khambhampaty, Global Head of Biologics at Dr Reddy’s Laboratories, said the launch was an important milestone for the company’s biologics business and would support its focus on complex biosimilars.
M V Ramana, CEO, Global Generics, Dr Reddy’s Laboratories, said the launch would expand the company’s presence in immuno-oncology and provide patients with an affordable treatment option.
NIVORZ is a fully human monoclonal antibody targeting the PD-1 immune checkpoint and is administered through intravenous infusion. It is available in single-dose vials of 40 mg/4 mL, 100 mg/10 mL and 240 mg/24 mL.
Nivolumab has approved indications in India for multiple cancers, including non-small cell lung cancer, renal cell carcinoma, melanoma, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, colorectal cancer, oesophageal cancer, gastric cancer, gastroesophageal junction cancer, malignant pleural mesothelioma and hepatocellular carcinoma.
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