Amgen's biosimilar to Roche/Biogen's Rituxan gets FDA approval for rheumatoid arthritis
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The U.S. Food and Drug Administration (FDA) approved Amgen's (NASDAQ:AMGN) Riabni, a biosimilar to Roche's (OTCQX:RHHBY) (OTCQX:RHHBF) and Biogen's (BIIB) blockbuster drug Rituxan, to be used in combination with methotrexate to treat adults with moderate to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

Amgen said Riabni is now approved for all Rituxan indications.
Riabni (rituximab-arrx) is already approved to treat adult patients with Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis and Microscopic Polyangiitis.
Biogen had noted in its Q1 release that its FY22 outlook assumes a continued declines in Rituxan revenue due to biosimilar competition.
Meanwhile, Roche had said that in Q1 the impact of competition from biosimilars for its cancer drugs Avastin, MabThera/Rituxan and Herceptin had further slowed down as expected (combined CHF568M off sales reduction).