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Dr. Reddy’s Laboratories has entered into an exclusive agreement with Sanofi to promote and distribute nirsevimab in India—a single-dose monoclonal antibody designed to protect all infants from respiratory syncytial virus.
On 28 April 2025, Dr. Reddy’s Laboratories Ltd. announced an exclusive distribution agreement with Sanofi Healthcare India Pvt. Ltd. for the launch of nirsevimab, a long-acting monoclonal antibody aimed at protecting infants and young children from serious respiratory syncytial virus (RSV) infections.
The agreement gives Dr. Reddy’s exclusive rights to market and distribute the drug in India, reflecting a deepening of its strategic partnership with Sanofi. It allows passive immunization through a single dose, providing immediate protection—especially valuable in a setting like India, where early life exposure to RSV is common. The launch is expected in the second quarter of fiscal year 2025–26, expanding access to this innovative therapy across the country.
A Breakthrough for Infant Respiratory Health
Nirsevimab is designed as a single-dose intramuscular injection to curb lower respiratory tract disease caused by RSV in:
RSV is a leading cause of serious respiratory illness in infants worldwide. In 2019, the virus was responsible for an estimated 33 million cases of lower respiratory infections, with over 3 million hospitalizations and about 26,300 in-hospital deaths globally among kids under 5 years. India bears a prominent share of this burden owing to its large birth cohort and variable access to healthcare.
Regulatory Progress
Nirsevimab has already secured regulatory approvals in several key markets including the European Union, United States, China, and Japan. In India, the Central Drugs Standard Control Organization (CDSCO) approved the drug for marketing in June 2024. The upcoming launch marks the product’s official commercial rollout in the Indian market.
Strategic Timing
The announcement aligns with World Immunization Week 2025, underscoring the importance of expanding access to vaccines and immunization-related treatments that safeguard young lives. Nirsevimab fills a vital preventive care gap for infants who may not qualify for vaccination or are too young to mount adequate immune responses.
Press release (Dr. Reddy's)
Dr. Reddy’s and Sanofi Healthcare India Private Limited expand partnership to launch Beyfortus® (nirsevimab), a novel drug for preventing Respiratory Syncytial Virus in India
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