Teva to launch first biosimilar for Roche’s MabThera

Teva Pharmaceuticals and Celltrion Healthcare today announced the availability of Truxima (rituximab-abbs) injection as the first biosimilar to the reference product Roche’s MabThera (rituximab) in the U.S.

Truxima is currently indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

“We are excited about the first FDA-approved biosimilar to rituximab in the U.S.,” stated Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva. “Teva’s commitment to biosimilars is focused on the potential to create lower healthcare costs and increased price competition. This focus is consistent with Teva’s mission of making accessible medications to help improve the lives of patients.”

In May 2019, the FDA approved Truxima to match all of the reference product’s oncology indications for NHL and CLL. In light of a patent settlement with Genentech, Celltrion and Teva have a pending FDA submission for rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA), and a license from Genentech to expand the TRUXIMA label to include these indications in Q2 2020.

Cellitron’s Truxima was registered with the TGA in 2018 and is currently not subsidised on the PBS. Sandoz’s MabThera biosimilar Riximyo is already on the PBS.

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