FDA approves Amjevita (adalimumab-atto) ,biosimilar, for all indications of the originator drug Humira (adalimumab).-Amgen

Amgen has announced that the 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.

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 III studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The Phase III 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.

Comment: The patents to Humira expire in the EU in 2016 and in the US in 2018.