FDA approves Riabni ,a rituximab biosimilar ,for moderate to severe rheumatoid arthritis.
Amgen announced that the FDA has approved Riabni (rituximab-arrx), a biosimilar to Rituxan, in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Riabni is already approved for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (also called Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).
Riabni, a CD20-directed cytolytic antibody, was proven to be highly similar to, with no clinically meaningful differences in safety or efficacy from, Rituxan (rituximab) based on totality of evidence, which included comparative analytical, non-clinical and clinical data.
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