FDA Approves Fourth Biosimilar Drug Amjevita
In adults, Amjevita has been approved 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.
In patients aged ≥4 years, Amjevita has been approved to treat moderately to severely active polyarticular juvenile idiopathic arthritis.
Amjevita is not interchangeable with Humira. A biosimilar is a biological product that is approved based on showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency from the reference product, as well as meeting other criteria specified by law.
The approval of Amjevita was based on the FDA's review of data that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and efficacy data that shows Amjevita is biosimilar to Humira.
Amjevita carries a Boxed Warning regarding an increased risk of serious infections leading to hospitalization or death. It also notes that lymphoma and other malignancies have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products.
For more information call (800) 772-6436 or visit FDA.gov.