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Dr. Reddy's Laboratories received U.S. FDA approval for its rituximab biosimilar on August 1, 2026
RDYDR Reddys Laboratories Ltd
Dr. Reddy's Laboratories received U.S. FDA approval for its rituximab biosimilar on August 1, 2026. This regulatory milestone strengthens the company's global biosimilars portfolio and advances its business in the United States. The product was developed, manufactured, and submitted by Dr. Reddy's following a successful Pre-License Inspection at its biologics facility in Hyderabad. Under a commercialization agreement, Fresenius Kabi holds exclusive rights to market the drug in the U.S., one of the world's largest pharmaceutical markets. The biosimilar has already been commercialized in India, the European Union, the United Kingdom, and over 25 emerging markets, with approvals also secured in Switzerland and Canada. Dr. Reddy’s Laboratories Limited is a global pharmaceutical company headquartered in Hyderabad, India, specializing in APIs, generics, branded generics, biosimilars, and OTC products across major therapeutic areas including oncology and immunology.