Dr. Reddy’s Laboratories has received approval from the U.S. Food and Drug Administration (FDA) for its rituximab biosimilar, a biosimilar version of Rituxan® (rituximab), marking another significant milestone in the company's expanding global biosimilars business.
The approval enhances Dr. Reddy’s biologics portfolio and reinforces its presence in the highly regulated U.S. pharmaceutical market. The biosimilar was developed, manufactured, and submitted for approval entirely by Dr. Reddy’s Laboratories.
The FDA approval follows a successful Pre-License Inspection (PLI) of the company’s biologics manufacturing facility in Bachupally, Hyderabad, demonstrating the company's manufacturing capabilities and compliance with stringent U.S. regulatory standards.
Under an existing commercialization agreement, Fresenius Kabi will hold the exclusive rights to market and distribute the rituximab biosimilar in the United States.
Commenting on the approval, Sridevi Khambhampaty, Global Head – Biologics at Dr. Reddy’s Laboratories, said the FDA's decision highlights the company's expertise in developing and manufacturing complex biologic medicines for global markets while reinforcing its long-term commitment to expanding patient access through biosimilars.
The rituximab biosimilar is already available in India, the European Union, the United Kingdom, and more than 25 emerging markets. It has also secured marketing approvals in Switzerland and Canada, reflecting its growing international acceptance.
Rituximab is a monoclonal antibody that targets the CD20 protein present on B-cells. It is widely prescribed for treating several B-cell cancers, including non-Hodgkin lymphoma and chronic lymphocytic leukemia (CLL), as well as autoimmune disorders such as rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).
The FDA approval is supported by extensive analytical, non-clinical, and clinical data demonstrating that the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, purity, or efficacy, meeting all FDA biosimilar approval requirements.
The latest approval further strengthens Dr. Reddy's strategy of expanding its biosimilars footprint globally while increasing access to advanced biologic therapies for patients worldwide.
