FDA grants first interchangeable rituximab biosimilar

FDA has designated Truxima (rituximab-abbs) as the first interchangeable rituximab biosimilar in the United States.

The designation does not change Truxima's approved indications, which include non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. However, interchangeability may reduce barriers to biosimilar use by supporting broader adoption across infusion centers, health systems, and payers, potentially improving patient access and lowering treatment costs.

Truxima was already approved as a biosimilar to Rituxan (rituximab) for all adult indications of the reference product. As the first rituximab biosimilar to receive interchangeability status, it will also receive the associated period of first interchangeable biosimilar exclusivity, according to Celltrion.

Sources: Celltrion. (2026, July 1). Celltrion secures FDA’s 1st interchangeable status for Rituximab biosimilar