Dr. Reddy’s proposed rituximab biosimilar BLA accepted for review by FDA

Dr. Reddy’s Laboratories announced that its Biologics License Application for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration. This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency and the United Kingdom’s Medicines and Healthcare products Regulatory Agency. In January 2023, Dr. Reddy’s had announced the completion of the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, European Union, and other regions. The submission of its dossier in April 2023 was based on a comprehensive data package including robust structural and functional analytical comparison data using multiple orthogonal techniques, pre-clinical, and head-to-head clinical studies that demonstrate similarity in pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity with the EU and U.S. reference products.