Amgen’s Amgevita, an adalimumab biosimilar to AbbVie’s Humira®, received approval from the European Commission on March 23, 2017. Adalimumab is a TNF (tumor necrosis factor) inhibitor that binds to TNF-alpha (TNF-α) preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases.
Amgevita received approval in all available indications, including the treatment of certain 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. According to the announcement, the European Commission 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).
The approval of Amgevita is the first approved biosimilar for Amgen in Europe. Amgen’s adalimumab biosimilar was approved by the FDA in September 2016, and is sold in the United States under the name Amjevita (adalimumab-atto).