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FDA Approves Amjevita, the First Humira Biosimilar
The FDA has approved the biosimilar Amjevita (adalimumab-atto, Amgen) across all eligible indications of the reference product, Humira (adalimumab).
Amjevita, the first adalimumab biosimilar approved by the FDA, is indicated for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease, and moderate-to-severe ulcerative colitis. The product is Amgen's first biosimilar to receive regulatory approval.
The approval of Amjevita was based on a comprehensive data package supporting biosimilarity to adalimumab using analytical, nonclinical, pharmacokinetic, and clinical data, including results from two phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The phase 3 studies each met their primary endpoint showing clinical equivalence to adalimumab. The safety and immunogenicity of Amjevita were also comparable to adalimumab.
Amgen’s biosimilar adalimumab is also undergoing review by the European Medicines Agency, following a regulatory application submitted in December 2015. Biosimilar adalimumab is one of nine programs included in Amgen’s pipeline of biosimilars.
The active ingredient of Amjevita is an anti-tumor necrosis factor-alpha monoclonal antibody that has the same amino acid sequence as, and is highly similar to, adalimumab. It will be delivered in prefilled syringe and auto-injector presentations to support dosing in each of the approved indications.
Source: Amgen; September 23, 2016.