Biosimilar Update: FDA Accepts Dr. Reddy’s Proposed Rituximab Biosimilar Application for Review

This closely follows acceptance of its rituximab biosimilar data for review by the European Medicines Agency and the United Kingdom’s Medicines and Healthcare products Regulatory Agency.

Dr. Reddy’s Laboratories Ltd’s 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 (FDA). 

This closely follows acceptance of its rituximab biosimilar data for review by the European Medicines Agency and the United Kingdom’s Medicines and Healthcare products Regulatory Agency. 

In January 2023, Dr. Reddy’s 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 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.

DRL_RI is being developed as a biosimilar of Rituxan/ MabThera (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. Rituxan / MabThera is approved for various indications including for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and more than 25 emerging markets. The company is currently collaborating with its partner Fresenius Kabi to commercialise its proposed biosimilar of rituximab in the United States.