Amgen's (AMGN) AMJEVITA Approved by U.S. FDA

September 26, 2016 6:23 AM EDT

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Amgen (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (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.

"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," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This milestone exemplifies our ongoing dedication to the development of high quality biologic medicines."

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.

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