On 1 August 2026, the Economic Times reported that the FDA has approved Dr Reddy’s biosimilar to Genentech’s Rituxan® (rituximab). The product will be commercialised in the US by Fresenius Kabi.
The FDA approval follows a Complete Response Letter (CRL) issued to Dr Reddy’s by the FDA in April 2024 regarding its biosimilar rituximab BLA. The CRL related to the results of regulatory inspections at Dr Reddy’s Biologics facility in 2023, as well as “certain aspects pertaining to the BLA”. Also in 2024, a settlement was reached in relation to patent infringement claims brought in the US District Court for the District of New Jersey by Genentech, Roche and Biogen against Dr Reddy’s and Fresenius Kabi in respect of Dr Reddy’s rituximab. The terms of the settlement are confidential.
Dr Reddy’s rituximab biosimilar is already commercialised in more than 28 markets, including India (marketed as Reditux®) and Europe (marketed as Ituxredi®), and has also received marketing approval in Switzerland and Canada.
Rituxan® was first approved in the US on 26 November 1997 and was one of the first mAbs to face biosimilar competition. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020, interchangeability status announced July 2026), Pfizer’s Ruxience® (launched in January 2020) and Amgen and Allergan’s Riabni™ (approved by the FDA in December 2020).