The Division of Drug Information at the U.S. Food and Drug Administration (FDA) has announced its approval of Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for the treatment of multiple inflammatory diseases, including inflammatory bowel diseases (IBDs).
The FDA approved Amjevita for the treatment of a number of inflammatory diseases, including moderate-to-severe active Crohn’s disease and moderate-to-severe active ulcerative colitis (UC), as well as moderate-to-severe active rheumatoid arthritis (RA), active psoriatic arthritis, active ankylosing spondylitis (a specific form of arthritis that affects the spine), moderate-to-severe plaque psoriasis, and moderate-to-severe active polyarticular juvenile idiopathic arthritis (in patients older than 4 years old).
Amjevita is an anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody developed by Amgen, Inc. in 2015. In clinical trials, Amjevita-treated patients reported infections and malignancies as its most serious side effects. The most common expected adverse reactions to the biosimilar are infections and injection-site reactions.
The FDA approved Amjevita based on the review of clinical evidence, including the characterization of the drug’s function and structure, data on animal studies, data on human pharmacokinetic and pharmacodynamic profiles, and data on clinical immunogenicity, among other safety and efficacy evidence. The review concluded that Amjevita is a biosimilar to Humira, but it is not approved as an interchangeable product; an interchangeable product is expected to produce the same clinical result as the reference product in any given patient.
“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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.
Not unlike Humira, Amjevita’s labeling includes a boxed warning to inform patients and healthcare providers about the risks of serious infections that might lead to hospitalizations. In addition, the warning alerts that lymphoma, among other potentially fatal diseases, has been reported in children and teenaged patients who received treatment with tumor necrosis factor blockers, such as adalimumab.
The drug must be dispensed together with a patient medication guide describing all necessary information on how to use Amjevita and the associated risks.
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