Dr. Reddy’s forays into India’s biosimilar immuno-oncology market, launches Nivorz
In 2025, the immuno-oncology market in India was estimated to be around ₹3,900 crore and predominantly driven by checkpoint inhibitors such as nivolumab, pembrolizumab and toripalimab.
Dr. Reddy's Laboratories announced on Tuesday that it is entering India's biosimilar immuno-oncology market with the launch of Nivorz, a biosimilar version of Bristol Myers Squibb's Opdivo (nivolumab). The company developed and manufactured Nivorz entirely at its biologics facility in Bachupally, Hyderabad. This launch demonstrates Dr. Reddy's end-to-end capabilities in the biosimilar value chain, from development to commercialization.
India's immuno-oncology market was estimated to be around ₹3,900 crore in 2025, primarily driven by checkpoint inhibitors such as nivolumab, pembrolizumab, and toripalimab. CEO M.V. Ramana stated that the launch strengthens their oncology portfolio and expands their presence in immuno-oncology, as access to immunotherapy remains a challenge for many patients.
Nivorz underwent a multi-country clinical development program involving 288 patients, including 252 Indians and 36 Russians, and demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference nivolumab. The Drug Controller General of India (DCGI) approved Nivorz based on these results. Sridevi Khambhampaty, Dr. Reddy's Global Head of Biologics, emphasized that the launch marks a significant milestone for their biologics business, reinforcing their commitment to expanding patient access to high-quality and complex biosimilars.
Nivorz is one of the immunotherapy agents with the broadest approved indications in Indian oncology, covering early-stage, locally advanced, recurrent, and metastatic disease settings across solid and hematological malignancies.
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