Blog Big Molecule Watch May 05, 2020

TRUXIMA launches as first U.S. Rituxan® biosimilar approved for RA

Teva and Celltrion Healthcare announced today the U.S. launch of TRUXIMA® (rituximab-abbs) for rheumatoid arthritis (RA).  TRUXIMA®, which originally launched in November 2019, is now approved to treat RA, non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyaniitis (MPA) in adult patients.  According to the press release, it is the first and only biosimilar to RITUXAN® available to treat RA in the U.S., and was approved by the FDA to match RITUXAN®’s oncology indications in May 2019.

 

TRUXIMA®’s launch is the result of joint partnership between Teva and Celltrion to commercialize TRUXIMA® in the U.S. and Canada.  Teva and Celltrion settled their BPCIA litigation against Genentech shortly before the November 2019 launch.

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