CDSCO Clears Lupin to Manufacture, Market Nivolumab Biosimilar for Cancer Treatment
New Delhi: Lupin Limited has received approval to manufacture and market a biosimilar version of nivolumab, Bristol Myers Squibb's blockbuster cancer immunotherapy, in India.
According to the recent news reported by ET, the approval was granted earlier this week and covers the indications approved for the innovator product. It is supported by a local Phase III study conducted by Lupin to evaluate the biosimilar’s efficacy, immunogenicity and pharmacokinetics against the reference medicine.
The company has also been directed to undertake a Phase IV study to further assess its safety and efficacy in real-world clinical practice.
The Mumbai-headquartered pharmaceutical company has obtained clearance for both the finished formulation and the bulk drug, or raw material. It will manufacture the medicine in collaboration with Virchow Biotech, a contract development and manufacturing organisation headquartered in Hyderabad.
Nivolumab is a biologic medicine indicated for 12 cancer indications, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma or kidney cancer, and head and neck squamous cell carcinoma (HNSCC). It works through an immune checkpoint mechanism by blocking the PD-1 receptor on T cells, enabling the immune system to generate a stronger and more sustained response against tumours.
Marketed by Bristol Myers Squibb under the brand name Opdivo, nivolumab is among the company’s leading revenue-generating products. The medicine is sold in more than 65 countries and recorded global sales exceeding $10 billion in 2025.
Ahmedabad-based Zydus Lifesciences became the first company to introduce a nivolumab biosimilar in India in January this year, following a legal dispute with the innovator. Subsequently, Dr Reddy’s Laboratories entered the market in September with its biosimilar, marketed under the brand name Nivorz.
Zydus markets its biosimilar as Tishtha in 100 mg and 40 mg strengths, priced at Rs 28,950 and Rs 13,950, respectively. The company claims that its product costs approximately one-fourth of the innovator brand’s price.
ET reported that India’s immuno-oncology market is valued at approximately Rs 3,900 crore, with nivolumab accounting for a substantial share. The medicine also serves the largest group of patients eligible for treatment with PD-1 inhibitors.
