Dr Reddy's Laboratories announced on Saturday (August 1) that it has received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar, a biosimilar version of Rituxan (rituximab), for the US market. According to reports from CNBC TV18 and Business Standard, this approval strengthens the Hyderabad-based drugmaker's biosimilars portfolio and marks another step in expanding its presence in the US pharmaceutical market. The product was developed, manufactured and submitted for approval by Dr Reddy's, with the approval following a recent Pre-License Inspection (PLI) conducted by the US FDA at the company's biologics manufacturing facility in Bachupally, Hyderabad. As per Business Standard, the approval 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 will hold exclusive rights to commercialise the rituximab biosimilar in the US market. As reported by CNBC TV18, Sridevi Khambhampaty, Global Head, Biologics, Dr Reddy's Laboratories, stated that the approval reflects the company's capabilities in developing and manufacturing complex biologic medicines for global markets. According to Business Standard, Fresenius Kabi holds the exclusive rights to commercialize the product in the United States, one of the world's most important pharmaceutical markets. The rituximab biosimilar is already commercialised in India, the European Union, the United Kingdom and more than 25 emerging markets, with marketing approval also received in Switzerland and Canada.
Rituximab is a monoclonal antibody that targets the CD20 antigen on B lymphocytes and is used in the treatment of several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, as well as certain autoimmune conditions. According to CNBC TV18, the FDA approval is based on analytical, non-clinical and clinical data that demonstrated the biosimilar's similarity to the reference product, with no clinically meaningful differences in safety, purity and potency. The company has been expanding its biosimilars business with a focus on oncology and immunology therapies.
Dr Reddy's currently has six commercial biosimilar products marketed in India, with some products available in over 30 countries. As reported by CNBC TV18, the company has been expanding its biosimilars business with a focus on oncology and immunology therapies. The FDA approval represents a significant milestone in the company's strategy to strengthen its position in the global biosimilars market through complex biologic medicine development and manufacturing capabilities.
