FDA Okays Amgen's AMJEVITA For Treatment Of Seven Inflammatory Diseases

(RTTNews) - Amgen (AMGN) said that the U.S. Food and Drug Administration has approved AMJEVITA or adalimumab-atto across all eligible indications of the reference product, Humira or adalimumab.

AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved 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. AMJEVITA is Amgen's first biosimilar to receive regulatory approval.

The approval of AMJEVITA was based on a comprehensive data package supporting biosimilarity to adalimumab based on 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. Safety and immunogenicity of AMJEVITA were also comparable to adalimumab.

The company'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 robust pipeline of biosimilars.