FDA Approves Amgen’s Amjevita as a Biosimilar to Humira

The U.S. Food and Drug Administration (FDA) has approved Amgen’s Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for the treatment of moderately to severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis and moderate to severe plaque psoriasis. Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years and older. FDA approval is based on review of evidence that demonstrates Amjevita is biosimilar to Humira. The most serious known side effects with the drug are infections and malignancies, and the most common expected adverse reactions are infections and injection site reactions.

“This is the fourth FDA-approved biosimilar,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions.”