Dr. Reddy’s has launched NIVORZ (Nivolumab Biosimilar) in India, a biosimilar to Opdivo (nivolumab).

With this, the company marks its entry into biosimilar immuno-oncology in the country. Developed and manufactured entirely in-house at the company’s biologics facility in Bachupally, Hyderabad, it reflects Dr. Reddy's end-to-end capabilities across the biosimilar value chain, from development through commercialisation.

Oncology remains an important focus area for Dr. Reddy's. The launch of NIVORZ further strengthens the company's oncology portfolio and expands its presence in immuno-oncology. The immuno-oncology market in India is estimated at approximately INR 3,900 crore in 2025 and is predominantly driven by checkpoint inhibitors such as nivolumab, pembrolizumab and toripalimab.

Access to immuno-oncology therapies remains a challenge for many patients due to the cost and duration of treatment. Through NIVORZ, Dr. Reddy's aims to broaden access to high-quality nivolumab therapy with an affordable biosimilar option for eligible patients.

NIVORZ was evaluated through a multi-country clinical development program involving 288 patients, including 252 from India and 36 from Russia, and demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference nivolumab. Based on this clinical development program, NIVORZ has been approved in India by the Drugs Controller General of India (DCGI).

Dr. Sridevi Khambhampaty, Global Head of Biologics, Dr. Reddy’s, said, "The launch of NIVORZ marks an important milestone for our biologics business. It reinforces our commitment to expanding patient access to high-quality biologic therapies, strengthens our oncology portfolio and reflects our continued focus on developing complex biosimilars."

NIVORZ (Nivolumab) is one of the immunotherapy agents with the broadest range of approved indications in oncology in India, including Metastatic Non-Small Cell Lung Cancer (NSCLC), Renal Cell Carcinoma (RCC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Melanoma, Classical Hodgkin Lymphoma (cHL), Urothelial Carcinoma (UC), Colorectal Cancer (CRC), Esophageal Squamous Cell Carcinoma (ESCC), Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma (GC, GEJC or EAC), Adjuvant treatment of Resected Esophageal or Gastroesophageal Junction Cancer (EC or GEJC), Malignant Pleural Mesothelioma (MPM) and Hepatocellular Carcinoma (HCC).

Together, these approved indications span early stage, locally advanced, recurrent, and metastatic disease settings across both solid and hematological malignancies.

M.V. Ramana, CEO—Global Generics, Dr. Reddy's, said, "The launch of NIVORZ strengthens our oncology portfolio and expands our presence in immuno-oncology. As access to immunotherapy continues to be a challenge for many patients, we remain committed to improving access to high-quality treatment options through affordable biosimilars such as NIVORZ."