The U.S. Food and Drug Administration (FDA) has approved Amgen’s Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab, AbbVie) for use in multiple inflammatory diseases, including psoriasis.
Amjevita is now approved to treat patients with active psoriatic arthritis, moderate-to-severe plaque psoriasis, active ankylosing spondylitis (a specific form of arthritis that affects the spine), moderate-to-severe active polyarticular juvenile idiopathic arthritis (in patients older than 4 years old), moderate-to-severe active Crohn’s disease and moderate-to-severe active ulcerative colitis (UC), and moderate-to-severe active rheumatoid arthritis (RA).
Like Humira, Amjevita is a TNF-inhibiting anti-inflammatory biologic medication. It binds to tumor necrosis factor-alpha (TNFα), which normally binds to TNFα receptors, leading to the inflammatory response of autoimmune diseases. By binding to TNFα, the drug reduces this inflammatory response. Amjevita is administrated subcutaneously.
According to Amgen, Amjevita will be available in a prefilled syringe and autoinjector presentations to support dosing in each of its approved indications.
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.
Amjevita is only the fourth so-called biosimilar — a biologic medical product that is almost an identical copy of an original product manufactured by a different company — to be approved by the FDA. Biosimilars were authorized as part of the federal healthcare overhaul to reduce spending on biotech drugs, much as generics have cut the costs of medicines.
The FDA considered that Amjevita proved to be a biosimilar of Humira based on clinical safety and effectiveness data, as well as other metrics, such as characterization of the drug’s function and structure, data on animal studies, data on human pharmacokinetic and pharmacodynamic profiles, and data on the drug’s clinical immunogenicity.
“Approval of AMJEVITA is an exciting accomplishment as it marks a new chapter in Amgen’s story of being a leader in biotechnology. In addition, AMJEVITA holds the potential to offer patients with chronic inflammatory diseases an additional treatment option,” Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said in a press release.
Like Humira, Amjevita contains a Boxed Warning with detailed information about its approved uses, as well as its potential increased risk of serious infections. The most serious known adverse reactions with Amjevita are infections and malignancies.