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Biogen, Genentech and Roche Sue Dr Reddy’s and Fresenius Kabi Alleging Infringement of 15 Rituxan®/MabThera® Rituximab Patents in NJ

Nov 17, 2023

Biogen, Genentech and Roche instigated proceedings against Dr Reddy’s Laboratories and Fresenius Kabi, alleging infringement of 15 patents relating to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) products in the US District Court of New Jersey.  The alleged infringement arises from Dr Reddy’s submission of its Abbreviated Biologic License Application (aBLA) to the FDA seeking approval for DRL_RI, its Rituxan® biosimilar.  The originators allege that Fresenius assisted Dr Reddy’s in its aBLA application.

On 12 July 2023, Dr Reddy’s announced its BLA for DRL_RI was accepted for review by the FDA following acceptance of its DRL_RI dossier by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) filed in April 2023.