Pharma major Dr Reddy’s Laboratories has secured approval from the U.S. Food and Drug Administration (FDA) for its rituximab biosimilar, a biosimilar to Rituxan (rituximab), for the US. 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 commercialisation 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,” Sridevi Khambhampaty, Global Head, Biologics, Dr. Reddy’s Laboratories said in a release on Sunday,The rituximab biosimilar has been commercialised 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.Rituximab is a monoclonal antibody that selectively targets the CD20 protein expressed on B-cells. By binding to CD20, rituximab induces B-cell depletion through multiple immune-mediated mechanisms.In the US, rituximab is approved for the treatment of adults with several hematologic malignancies and autoimmune diseases, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).Published on August 2, 2026