Dr Reddy's Laboratories has launched NIVORZ, a biosimilar to nivolumab (Bristol Myers Squibb's blockbuster drug Opdivo), in India, marking the drugmaker's entry into biosimilar immuno-oncology in the country. According to reports from CNBC TV18 and Rediff Moneynews, the company developed and manufactured NIVORZ entirely in-house at its biologics facility in Bachupally, Hyderabad. The drug has been approved by the Drugs Controller General of India (DCGI) following a multi-country clinical development programme involving 288 patients, including 252 from India and 36 from Russia. Sridevi Khambhampaty, Global Head of Biologics at Dr Reddy's, called it an important boost for the company's cancer treatment lineup, emphasizing that NIVORZ is all about helping more people get life-saving therapies without breaking the bank. M.V. Ramana, CEO Global Generics at Dr Reddy's, stated that the launch strengthens the company's oncology portfolio and expands presence in immuno-oncology, with the company remaining committed to improving access to high-quality treatment options through affordable biosimilars.
The study showed comparable efficacy, safety, pharmacokinetics and immunogenicity between NIVORZ and the reference nivolumab, as reported by CNBC TV18. 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. The intravenous drug helps restore the immune system's ability to identify and combat cancer cells, offering an affordable treatment option in the immuno-oncology segment.
NIVORZ is approved for 12 indications, including metastatic non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, melanoma, classical Hodgkin lymphoma, urothelial carcinoma, colorectal cancer, esophageal squamous cell carcinoma, gastric and gastroesophageal junction cancer, malignant pleural mesothelioma, and hepatocellular carcinoma across various disease stages, according to Rediff Moneynews. The approved uses cover early-stage, locally advanced, recurrent and metastatic cancers across solid and haematological malignancies. 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. The company said NIVORZ is intended to broaden access to nivolumab therapy through a more affordable biosimilar option, addressing the cost and duration of immunotherapy treatment that continue to limit access for many patients.
Sridevi Khambhampaty, global head of biologics at Dr Reddy's Laboratories, stated that the launch of NIVORZ marks an important milestone for the biologics business, as reported by CNBC TV18. She emphasized that 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, CEO Global Generics, highlighted that as access to immunotherapy continues to be a challenge for many patients, the company remains committed to improving access to high-quality treatment options through affordable biosimilars such as NIVORZ. Leaders at Dr Reddy's say NIVORZ is all about helping more people get life-saving therapies without breaking the bank, making immunotherapy easier to access for patients. The launch is significant as it strengthens the company's presence in oncology and provides an entry into immuno-oncology, a market estimated at around ₹3,900 crore in India in 2025.
Shares of Dr Reddy's Laboratories ended at ₹1,149 on Tuesday, down 1.42% from the previous close, according to CNBC TV18. The company noted that the cost and duration of treatment can make immuno-oncology therapies difficult for many patients to access, highlighting the potential market opportunity for biosimilars in this segment. The launch of NIVORZ is expected to expand affordable immuno-oncology options and strengthen the company's competitive position in the growing biosimilar market, with the homegrown version of the cancer drug Opdivo marking a significant step for the company as it enters the Indian biosimilar market. Zydus Lifesciences was the first company to launch a nivolumab biosimilar, with the patents for the drug expiring in May.
