FDA Approves Humira Biosimilar

September 26, 2016

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

FDA announced on Sept. 23, 2016 that it has approved Amgen’s Amjevita (adalimumab-atto), a biosimilar to Humira (adalimumab) for the treatment of a variety of inflammatory diseases including severely active polyarticular juvenile idiopathic arthritis.

Amjevita is being approved as a biosimilar, not an interchangeable product, to treat moderately to severely active 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. FDA based the approval on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data.

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

Amjevita’s label will contain a Boxed Warning on the risk of serious infections and the fact that lymphoma and other malignancies have been reported “in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products.” 

Source: FDA