On July 1, 2026, Celltrion announced that the FDA had granted interchangeability designation to TRUXIMA® (rituximab-abbs), Celltrion and Teva’s biosimilar to Genentech’s RITUXAN®. With this designation, TRUXIMA® became the first rituximab biosimilar to receive interchangeable status in the United States.
TRUXIMA®, originally approved by FDA in November 2018, is approved for the same indications as Genentech’s RITUXAN®, including non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA). Following settlement of its BPCIA litigation with Genentech in November 2018, Celltrion and Teva launched TRUXIMA® in the United States on November 11, 2019.
There are currently two other rituximab biosimilars approved by FDA—Amgen’s RIABNI® (rituximab-arrx) and Pfizer’s RUXIENCE® (rituximab-pvvr) —but neither product has been approved as interchangeable.