On August 1, 2026, Fresenius Kabi and Dr. Reddy’s Laboratories announced that the FDA had approved Dr. Reddy’s rituximab biosimilar, a biosimilar to Genentech’s RITUXAN® (rituximab). Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes and is used in the treatment of several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as autoimmune disorders such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
According to Fresenius, “[t]he FDA approval is supported by a totality of the evidence approach, including analytical, non-clinical, and clinical data demonstrating that the product is highly similar to and has no clinically meaningful differences from the reference product, Rituxan®, consistent with U.S. FDA requirements for biosimilar approval.” Dr. Reddy’s further noted that the biosimilar is already commercialized in India, the European Union, the United Kingdom, Switzerland, Canada, and more than 25 emerging markets. Under an existing commercialization agreement, Fresenius Kabi holds the exclusive rights to commercialize the rituximab biosimilar in the United States.
Fresenius Kabi and Dr. Reddy’s rituximab biosimilar joins a growing field of FDA-approved rituximab biosimilars, which includes Celltrion and Teva’s TRUXIMA (rituximab-abbs) (approved in November 2018), which was recently designated in July 2026 as the first interchangeable rituximab biosimilar; Amgen’s RIABNI (rituximab-arrx) (approved in July 2019); and Pfizer’s RUXIENCE (rituximab-pvvr) (approved in December 2020).