On 10 April 2024, as a result of a settlement between the parties, the US District Court for the District of New Jersey dismissed all patent infringement claims in the proceeding brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s Laboratories and Fresenius Kabi in respect of Dr Reddy’s proposed DRL_RI (rituximab), biosimilar to Genentech’s/Biogen’s Rituxan®. The terms of the settlement between the parties have not been publicly disclosed.
The proceeding was commenced on 17 November 2023, following Dr Reddy’s submission of its aBLA to the FDA seeking approval for DRL_RI. DRL_RI was to be commercialised by Fresenius in the US and by Dr Reddy’s in other jurisdictions.
Rituximab is an old molecule and was one of the first mAbs to become “biosimilar”, with the first rituximab approval in the US on 26 November 1997. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s RiabniTM (approved by the FDA in December 2020).