FDA reviews DRL_RI rituximab biosimilar for approval
Dr. Reddy’s Laboratories announced that its Biologics License Application (BLA) for DRL_RI biosimilar rituximab candidate has been accepted for a substantive review by the FDA
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 structural and functional analytical comparison data using multiple orthogonal techniques, pre-clinical, and head-to-head clinical studies that it claims demonstrate similarity in pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity with the EU and US reference products.
The submitted stuidies are RI-01-003 which demonstrated pharmacokinetic equivalence and similarity in pharmacodynamics, safety and immunogenicity between DRL_RI and EU reference medicinal product and U.S. reference product. The RI-01-006 (FLINTER) study demonstrated efficacy equivalence and similarity in safety and immunogenicity between DRL_RI and EU reference medicinal product in patients with Low Tumour Burden Follicular Lymphoma. Finally the RI-01-007 study demonstrated similar safety and immunogenicity profile between the DRL_RI, EU reference medicinal product and U.S. reference product groups upon single transition from either of them, in subjects with active rheumatoid arthritis.
The MabThera and Rituxan patents have expired.
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