FDA Approves Amgen’s RIABNI™ (Rituximab-arrx) for Adults With Moderate to Severe Rheumatoid Arthritis

On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen’s RIABNI (rituximab-arrx), a biosimilar to Genentech’s RITUXAN®, in combination with methotrexate for treatment of moderate to severely active rheumatoid arthritis (RA).  RIABNI has been approved since December 2020 for treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis), and Microscopic Polyangiitis (MPA).

According to Amgen, a phase 3 clinical study comparing RIABNI versus RITUXAN in patients with moderate to severe RA showed equivalence in clinical efficacy between RIABNI and RITUXAN.  Amgen currently has five biosimilar products approved in the U.S.