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Dr. Reddy’s rituximab biosimilar approved in the U.S., commercialized by Fresenius Kabi
01-Aug-2026, 09:55
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) announced that the U.S. Food and Drug Administration has approved its rituximab biosimilar, developed and manufactured by Dr. Reddy’s Laboratories, for the U.S. market, with Fresenius Kabi holding the exclusive rights to commercialize the product in the United States. The approval follows a recent Pre-License Inspection at the company's biologics manufacturing facility in Bachupally, Hyderabad, and strengthens Dr. Reddy’s global biosimilars portfolio.
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) announced that the U.S. Food and Drug Administration has approved its rituximab biosimilar, developed and manufactured by Dr. Reddy’s Laboratories, for the U.S. market, with Fresenius Kabi holding the exclusive rights to commercialize the product in the United States. The approval follows a recent Pre-License Inspection at the company's biologics manufacturing facility in Bachupally, Hyderabad, and strengthens Dr. Reddy’s global biosimilars portfolio.