On 1 July 2026, Celltrion announced that the FDA has granted interchangeability status to Truxima®, biosimilar to Genentech/Biogen’s Rituxan®, making it the first rituximab biosimilar in the US to earn this designation. As the first interchangeable rituximab biosimilar in the US, Truxima® has a 1-year exclusivity period, during which the FDA cannot approve subsequent interchangeable versions of Rituxan®.
Truxima® was launched in the US in May 2020 and is approved for all non-paediatric indications of Rituxan®, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and microscopic polyangiitis.
Rituxan® was first approved in the US on 26 November 1997 and was one of the first mAbs to become biosimilar. In addition to Truxima®, Amgen/Allergan’s Riabni® (approved December 2020) and Pfizer’s Ruxience® (launched January 2020) are the only rituximab biosimilars approved in the US market, with Dr Reddy’s biosimilar rituximab being knocked back by the FDA in April 2024.