Dr Reddy’s Strengthens Global Biosimilars Portfolio with US FDA Approval for Rituximab

Dr Reddy’s Laboratories has received approval from the US Food and Drug Administration (US FDA) for its rituximab biosimilar, a biosimilar version of Rituxan (rituximab), marking another important milestone in its global biosimilars journey. The product was developed, manufactured and submitted for approval by Dr Reddy’s, with the approval following a successful Pre-License Inspection (PLI) of its biologics manufacturing facility in Bachupally, Hyderabad. Under an exclusive commercialisation agreement, Fresenius Kabi will market the product in the US, further strengthening Dr Reddy’s presence in one of the world’s largest pharmaceutical markets. Rituximab is a monoclonal antibody used to treat several B-cell cancers, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, as well as certain autoimmune diseases. The approval was supported by analytical, non-clinical and clinical studies demonstrating no clinically meaningful differences from the reference product in terms of safety, purity and potency. The biosimilar is already commercialised in India, the European Union, the United Kingdom and more than 25 emerging markets, while it has also received marketing approvals in Switzerland and Canada. With six commercial biosimilar products already available in India and some products marketed in over 30 countries, the latest approval further reinforces Dr Reddy’s growing capabilities in complex biologics and its long-term focus on expanding oncology and immunology therapies globally. $DRREDDY Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.