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Stock Report
Dr. Reddy's Laboratories Receives U.S. FDA Approval for Rituximab Biosimilar
Posted On : 2026-08-01 14:40:45( TIMEZONE : IST )
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) today announced that the U.S. Food and Drug Administration (FDA) has approved its rituximab biosimilar, a biosimilar to Rituxan® (rituximab), for the U.S. market.
The approval further strengthens Dr. Reddy's growing global biosimilars portfolio and advances its biosimilars business in the United States.
The product was developed, manufactured and submitted for approval by Dr. Reddy's Laboratories. The approval follows the successful recent Pre-License Inspection (PLI) conducted by the U.S. FDA at the Company's biologics manufacturing facility in Bachupally, Hyderabad, and reflects the company's capabilities in bringing complex biologic medicines to highly regulated markets and its long-standing commitment to biosimilars.
Under a commercialization agreement, Fresenius Kabi holds the exclusive rights to commercialize the product in the United States, one of the world's most important pharmaceutical markets.
"The approval of the rituximab biosimilar on the FDA's goal date reflects our capabilities in developing and manufacturing complex biologic medicines for global markets," said Sridevi Khambhampaty, Global Head, Biologics, Dr. Reddy's Laboratories.
The rituximab biosimilar has been commercialized in India, the European Union, the United Kingdom and more than 25 emerging markets, and has also received marketing approval in Switzerland and Canada.
Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes and is widely used in the treatment of several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as certain autoimmune conditions.
The FDA approval is supported by a comprehensive body of analytical, non-clinical and clinical evidence demonstrating that the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, purity and potency, consistent with FDA requirements for biosimilar approval.
