Amgen: FDA OK's Riabni Biosimilar to Rituxan in Rheumatoid Arthritis
June 06 2022 - 9:50AM
Dow Jones News
By Colin Kellaher
Amgen Inc. on Monday said the U.S. Food and Drug Administration
approved the expanded use of its Riabni biosimilar to Rituxan in
certain patients with the chronic inflammatory joint disease
rheumatoid arthritis.
Amgen said the approval covers Riabni in combination with
methotrexate for adults with moderate to severely active rheumatoid
arthritis who have had an inadequate response to one or more tumor
necrosis factor antagonist therapies.
Biosimilars are near-copies of biologic drugs, such as Rituxan,
that are made from living cells and are analogous to generic copies
of traditional medicines.
Rituxan is jointly marketed by Biogen Inc. and Roche Holding
AG's Genentech unit.
The FDA previously approved Riabni for the treatment of adults
with non-Hodgkin's lymphoma, chronic lymphocytic leukemia,
granulomatosis with polyangiitis (also called Wegener's
granulomatosis) and microscopic polyangiitis.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 06, 2022 09:35 ET (13:35 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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