Dr. Reddy's Laboratories Ltd., a global pharmaceutical company based in Hyderabad, India, has reached a significant milestone in its pursuit of bringing a biosimilar rituximab to market. The company's proposal for the rituximab biosimilar, known as DRL_RI, has been accepted for review by multiple regulatory agencies.
In January 2023, Dr. Reddy's Laboratories announced the successful completion of clinical studies for DRL_RI. With this achievement under their belt, the company set its sights on filing applications with regulatory bodies in various regions, including the United States and European Union.
Fast forward to April 2023, and Dr. Reddy's Laboratories has made significant progress towards its goal. The company submitted a comprehensive dossier containing all relevant information about DRL_RI to regulatory agencies such as the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MH