FDA Approves Adalimumab Biosimilar

The US Food and Drug Administration has approved adalimumab-atto (Amjevita) as a biosimilar to adalimumab (Humira) for the treatment of multiple inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, active ankylosing spondylitis, moderate to severe Crohn disease, moderate to severe ulcerative colitis, moderate to severe plaque psoriasis, and moderate to severe polyarticular juvenile idiopathic arthritis.

The approval was based on a review of available evidence, including structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other data demonstrating clinical safety and effectiveness. While the drug has been approved as a biosimilar, it has not been approved as an interchangeable product.
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Serious adverse effects included infectious and malignancies, and the most common adverse effects were infections and injection site reactions.

Amjevita contains a Boxed Warning about increased risk of serious infections and reports of lymphoma and malignancies in children and adolescents treated with tumor necrosis factor blockers.

—Michael Potts

Reference:

FDA approves Amjevita, a biosimilar to Humira [press release]. Silver Spring, MD: US Food and Drug Administration; September 23, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm. Accessed September 26, 2016.