United States-based Amgen (NASDAQ:AMGN) announced on Monday that it has received approval from the United States Food and Drug Administration (FDA) for its RIABNI (rituximab-arrx), a biosimilar to Rituxan, in combination with methotrexate to treat adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumour necrosis factor (TNF) antagonist therapies.

RIABNI is already approved to treat adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukaemia (CLL), Granulomatosis with Polyangiitis (GPA) (also called Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). It is a CD20-directed cytolytic antibody that was proven to be highly similar to, with no clinically meaningful differences in safety or efficacy from, Rituxan (rituximab) based on totality of evidence that covered comparative analytical, non-clinical and clinical data.

The randomised, double-blind, comparative clinical study compared the efficacy, safety, pharmacokinetics and immunogenicity of RIABNI compared to rituximab reference product (RP) in patients with moderate to severe RA.