Dr Reddy's Labs proposed rituximab biosimilar application accepted for review by USFDA, EMA and MHRA
DRL_RI is being developed as a biosimilar of Rituxan / MabThera (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody.;
Hyderabad: Dr. Reddy’s Laboratories Ltd., a global pharmaceutical company, has announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA).
This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
In January 2023, Dr. Reddy’s had announced the successful 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.
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