Key Highlights:
- Dr. Reddy’s Laboratories has launched Nivorz, its biosimilar version of Bristol Myers Squibb’s nivolumab (Opdivo), marking the company’s entry into India’s biosimilar immuno-oncology segment.
- Approved by the DCGI for 12 cancer indications, Nivorz was evaluated in a multi-country clinical trial involving 288 patients from India and Russia and demonstrated comparable efficacy, safety, and immunogenicity to the reference drug.
- Nivorz will be available as 40 mg, 100 mg, and 240 mg single-dose vials, manufactured at Dr. Reddy’s Bachupally biologics facility in Hyderabad. The company said the launch strengthens its oncology portfolio and aims to expand access to immunotherapy.
Implications:
Dr. Reddy’s launch of Nivorz marks its entry into India’s biosimilar immuno‑oncology segment and adds a lower‑cost checkpoint inhibitor option across 12 approved cancer indications. In a ~₹3,900 crore Indian immuno‑oncology market dominated by originator PD‑1/PD‑L1 drugs, Nivorz is positioned to broaden access for patients who face high treatment costs, while strengthening Dr. Reddy’s oncology portfolio and leveraging its in‑house biologics capacity at the Bachupally facility.
Source: ET Pharma
