Dr Reddy’s announced its Biologics License Application (BLA) for DRL_RI, its proposed biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab), has been accepted for review by the FDA. This follows acceptance of its DRL_RI dossier for review by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Rituxan®/MabThera® is approved for rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
We reported on 20 January 2023 that Dr Reddy’s successfully completed clinical studies of DRL_RI for filing in the US, EU and other regions against Rituxan®. DRL_RI will be commercialised by Fresenius Kabi in the US, and by Dr Reddy’s directly in other jurisdictions.