Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Celltrion Healthcare, Co., Ltd., announced that TRUXIMA® (rituximab-abbs) injection is now available in the United States for the treatment of:
- Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies
- Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids
TRUXIMA is the only biosimilar to the reference product Rituxan® (rituximab) available to treat rheumatoid arthritis in the United States.
Celltrion Healthcare and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 for Teva to commercialize TRUXIMA in the U.S. and Canada. In May 2019, TRUXIMA was approved by the U.S. Food and Drug Administration (FDA).
The Wholesale Acquisition Cost (WAC or “list price”) for TRUXIMA will be 10 percent lower than the reference product. TRUXIMA is expected to be available through primary wholesalers at a WAC of $845.55 per 100mg vial and $4,227.75 per 500mg vial.