Amgevita treats select inflammatory diseases in adults, such as 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 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," Dr. Sean Harper, executive vice president of research and development at Amgen, said in a statement. "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."
Approval came after a Phase 3 clinical study that showed no clinically meaningful difference between the company’s product and the biosimilar adalimumab. With approval, the company can now market the product with unified labeling in all 28 EU member countries.
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