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European Commission approves adalimumab biosimilar for treatment of RA, PsA, AS, JIA
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The European Commission has approved Amgevita, a biosimilar to adalimumab, for all of its available indications.
These include the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, severe active ankylosing spondylitis, severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in addition to 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.
It is also approved for pediatric use for Crohn’s disease in children aged 6 years and older, severe chronic plaque psoriasis in children aged 4 years and older, enthesitis-related arthritis in children aged 6 years and older and polyarticular juvenile idiopathic arthritis in children aged 2 years and older.
“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,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said. “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.”
Amgevita (adalimumab-atto, Amgen) was approved in the United States last year.
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