MONDAY, Sept. 26, 2016 (HealthDay News) — Amjevita (adalimumab-atto) — a biosimilar drug similar to the popular anti-inflammatory drug Humira — has been approved by the U.S. Food and Drug Administration.
Amjevita has been approved for moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis (an arthritis that affects the spine); Crohn’s disease; ulcerative colitis; plaque psoriasis and juvenile idiopathic arthritis, the FDA said in a news release.
Biological drugs are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast, the FDA said.
A biosimilar drug is a biological product that’s sanctioned after its maker proves it is “highly similar” to an already-approved biologic drug. The manufacturer of the biosimilar drug must prove that the product has “no clinically meaningful differences” in safety, purity and potency from the already-approved one, the FDA said.
Amjevita is the fourth-ever FDA-approved biosimilar. Its most serious side effects include infection, cancerous conditions and injection-site reactions. Like Humira, it has a boxed warning of increased risk for serious infections that could lead to hospitalization or death. The warning also notes that lymphoma and other forms of cancer have been reported among children and teens who use this class of drug, known as a tumor necrosis factor blocker, the FDA said.
Amjevita is manufactured by Amgen Inc., in Thousand Oaks, Calif.
More information
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