The company said on Tuesday that NIVORZ was developed and manufactured at its biologics facility in Bachupally, Hyderabad. The drug has been approved by the Drugs Controller General of India following a multi-country clinical development programme involving 288 patients, including 252 from India and 36 from Russia.
The study showed comparable efficacy, safety, pharmacokinetics and immunogenicity between NIVORZ and the reference nivolumab, Dr Reddy’s said.
Drug approved for 12 cancer indications
NIVORZ is approved for 12 indications, including metastatic non-small cell lung cancer, renal cell carcinoma, melanoma, classical Hodgkin lymphoma, urothelial carcinoma, colorectal cancer, oesophageal cancer, gastric cancer, hepatocellular carcinoma and malignant pleural mesothelioma.
The approved uses cover early-stage, locally advanced, recurrent and metastatic cancers across solid and haematological malignancies, according to the company.
Nivolumab is a fully human monoclonal antibody that targets the programmed death-1, or PD-1, immune checkpoint. NIVORZ is administered through intravenous infusion and is available in 40 mg/4 mL, 100 mg/10 mL and 240 mg/24 mL single-dose vials.
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Dr Reddy’s targets growing immuno-oncology market
India’s immuno-oncology market was estimated at around ₹3,900 crore in 2025 and was largely driven by checkpoint inhibitors such as nivolumab, pembrolizumab and toripalimab, according to data cited by Dr Reddy’s.
The company said the cost and duration of treatment can make immuno-oncology therapies difficult for many patients to access.“The launch of NIVORZ marks an important milestone for our biologics business,” said Sridevi Khambhampaty, global head of biologics at Dr Reddy’s Laboratories.
She said the launch would expand patient access to biologic therapies, strengthen the company’s oncology portfolio and support its focus on developing complex biosimilars.
M.V. Ramana, chief executive officer, global generics, at Dr Reddy’s Laboratories, said the launch expands the company’s presence in immuno-oncology and aims to improve access to treatment through biosimilars.
Shares of Dr Reddy’s Laboratories ended at ₹1,149 on Tuesday, down 1.42% from the previous close.
