Hyderabad: Pharma major Dr Reddy’s Laboratories on Tuesday announced its foray into the Indian biosimilar immuno-oncology market with the rollout of its biosimilar version of Bristol Myers Squibb’s Opdivo (nivolumab).The biosimilar — Nivorz, developed and manufactured entirely in-house at its biologics facility in Bachupally, Hyderabad — has been approved by Drugs Controller General of India across 12 indications covering solid tumours and haematological malignancies, Dr Reddy’s said in a regulatory filing.The drug has been approved for use in lung, kidney, head and neck, melanoma, lymphoma, urothelial, colorectal, gastric, oesophageal, mesothelioma and liver cancers in India.Dr Reddy’s said the drug was evaluated in a multi-country clinical development programme involving 288 patients, including 252 in India and 36 in Russia. The company said the studies demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference nivolumab.Nivolumab is a fully human monoclonal antibody that targets the PD-1 immune checkpoint and helps restore the immune system’s ability to identify and fight cancer cells. The biosimilar, to be administered through intravenous infusion, will be available in single-dose vials of 40 mg/4 mL, 100 mg/10 mL and 240 mg/24 mL.Dr Reddy’s said the foray strengthens its oncology portfolio and expands its presence in immuno-oncology, a market that is estimated at about ₹3,900 crore in India as of 2025, driven mainly by checkpoint inhibitors including nivolumab, pembrolizumab and toripalimab.Dr Sridevi Khambhampaty, global head of biologics, Dr Reddy’s Labs, said Nivorz marks a key milestone for the company’s biologics business.MV Ramana, CEO of global generics at Dr Reddy’s, said affordable biosimilars can help address access challenges for cancer patients.
