Dr. Reddy’s Enters Indian Immuno-Oncology Market With Nivorz Biosimilar Launch

Dr. Reddy's Laboratories has officially entered the Indian biosimilar immuno-oncology market with the launch of Nivorz, a biosimilar version of Bristol Myers Squibb's blockbuster drug Opdivo, also known as nivolumab. The company confirmed that the drug has received approval from the Drugs Controller General of India for use across 12 distinct indications, including various solid tumours and haematological malignancies.

Nivorz was developed and manufactured entirely in-house at the company's biologics facility in Bachupally, Hyderabad. According to a regulatory filing, the drug's clinical validation involved a multi-country development programme with 288 patients, 252 of whom were based in India and 36 in Russia. The study results indicated that the biosimilar maintains comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference nivolumab product.

The launch marks a significant expansion of Dr. Reddy's oncology portfolio. The Indian immuno-oncology market, which relies heavily on checkpoint inhibitors such as nivolumab, pembrolizumab, and toripalimab, was valued at approximately ₹3,900 crore in 2025. By introducing a locally manufactured biosimilar, the company aims to address existing access challenges for cancer patients in the country.

Dr. Sridevi Khambhampaty, global head of biologics at Dr. Reddy's Labs, described the launch as a key milestone for the firm's biologics business. MV Ramana, CEO of global generics at Dr. Reddy's, emphasized that the availability of affordable biosimilars is critical for improving patient access to advanced cancer therapies.

Nivorz is designed for intravenous infusion and will be distributed in single-dose vials of 40 mg/4 mL, 100 mg/10 mL, and 240 mg/24 mL. The drug is approved for a wide range of cancer treatments in India, covering lung, kidney, head and neck, melanoma, lymphoma, urothelial, colorectal, gastric, oesophageal, mesothelioma, and liver cancers. The company has not yet disclosed specific pricing or regional rollout timelines beyond the initial launch announcement.