Posted by Michael Wonder on 24 Sep 2016
FDA approves Amgen's Amjevita (adalimumab-atto) for treatment of seven inflammatory diseases
23 September 2016 - First biosimilar adalimumab approved by FDA.
Amgen today announced that the U.S. FDA has approved Amjevita (adalimumab-atto) across all eligible indications of the reference product, Humira (adalimumab).
Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. Amjevita is Amgen's first biosimilar to receive regulatory approval.
