Dr. Reddy's Launches NIVORZ, India's In-House Nivolumab Biosimilar, Across 12 Oncology Indications
核心洞察
Dr. Reddy's Laboratories has launched NIVORZ (搜索), a nivolumab biosimilar to Opdivo, in India, marking its entry into the country's biosimilar immuno-oncology segment.
The Drugs Controller General of India (搜索) approved NIVORZ (搜索) across 12 indications spanning solid and haematological malignancies, including metastatic non-small cell lung cancer (搜索) and melanoma (搜索).
A multi-country programme in 288 patients, 252 from India and 36 from Russia, showed comparable efficacy, safety, pharmacokinetics and immunogenicity to reference nivolumab.
Dr. Reddy's Laboratories has launched NIVORZ (搜索), a biosimilar to Opdivo (nivolumab), in India, marking the company's entry into the country's biosimilar immuno-oncology segment. The product was developed and manufactured entirely in-house at Dr. Reddy's biologics facility in Bachupally, Hyderabad, reflecting what the company describes as end-to-end capabilities across the biosimilar value chain, from development to commercialisation.
The Drugs Controller General of India (搜索) (DCGI) approved NIVORZ (搜索) across 12 indications spanning solid and haematological malignancies. The intravenous therapy is intended to restore the immune system's ability to identify and combat cancer cells.
Approved Indications Span Early to Metastatic Disease
The approved indications cover early-stage, locally advanced, recurrent and metastatic disease settings. They include metastatic non-small cell lung cancer (搜索), renal cell carcinoma (搜索), squamous cell carcinoma of the head and neck, melanoma (搜索), classical Hodgkin lymphoma (搜索), urothelial carcinoma (搜索), colorectal cancer (搜索), esophageal squamous cell carcinoma (搜索), gastric and gastroesophageal junction cancer (搜索), malignant pleural mesothelioma (搜索), and hepatocellular carcinoma (搜索).
Nivolumab is an immunotherapy agent with a broad range of approved oncology indications in India, covering both solid and haematological malignancies.
Clinical Programme Enrolled 288 Patients
NIVORZ (搜索) was evaluated in a multi-country clinical development programme involving 288 patients, including 252 from India and 36 from Russia. According to the company, the programme demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference nivolumab.
The product is available in single-dose vials of 40 mg/4 mL, 100 mg/10 mL, and 240 mg/24 mL.
Access and Market Context
Dr. Reddy's said NIVORZ (搜索) 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.
The Indian immuno-oncology market was estimated at approximately Rs. 3,900 crore in 2025 and is predominantly driven by checkpoint inhibitors including nivolumab, pembrolizumab and toripalimab. Oncology remains a key focus area for Dr. Reddy's, with the launch expanding its oncology portfolio and strengthening its presence in immuno-oncology.
Dr. Sridevi Khambhampaty, Global Head of Biologics at Dr. Reddy's Laboratories, said, "The launch of NIVORZ (搜索) 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."
M.V. Ramana, CEO, Global Generics, Dr. Reddy's Laboratories, said, "The launch of NIVORZ (搜索) 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."