Regulatory Affairs

Amgen’s Amgevita secures approval in Europe for certain inflammatory diseases

Published 24 March 2017

Amgen’s Amgevita (biosimilar adalimumab) has been granted the marketing authorization by the European Commission (EC) in all available indications.

Amgevita is authorized for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; severe active ankylosing spondylitis (AS); severe axial spondyloarthritis without radiographic evidence of AS; moderate-to-severe chronic plaque psoriasis; moderate-to-severe hidradenitis suppurativa; non-infectious intermediate, posterior and panuveitis; moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis.

The EC also approved Amgevita for the treatment of certain pediatric inflammatory diseases, including moderate-to-severe Crohn's disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen said: "The approval of our first biosimilar by the European Commission is a major milestone not just for Amgen as a company, but for the millions of patients with chronic inflammatory diseases who need alternative treatment options.

"In addition, Amgevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option. This milestone exemplifies our ongoing dedication to the development of high-quality biologic medicines."

The EC approved Amgevita based on a comprehensive data package supporting biosimilarity to adalimumab based on analytical, 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 no clinically meaningful differences to adalimumab. Safety and immunogenicity of Amgevita were also comparable to adalimumab.

Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.

Amgevita was approved in the United States (U.S.) by the U.S. Food and Drug Administration on Sept. 23, 2016. In the U.S., the brand name is AMJEVITA (adalimumab-atto).



Source: Company Press Release