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Dr Reddy’s proposed biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) will be reviewed by FDA, EMA and MHRA

Jul 12, 2023

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.