The U.S. Food and Drug Administration approved the medicine, under the name Amjevita, in September 2016.
The European Commission also authorized Amgevita to be marketed as a treatment for adults with psoriatic arthritis, severe ankylosing spondylitis (AS), severe axial spondyloarthritis, moderate to severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa, moderate to severe ulcerative colitis, and non-infectious intermediate, posterior and panuveitis cases of moderate to severe Crohn’s disease.
The EC also approved Amgevita for children with four conditions: moderate to severe Crohn’s disease in children 6 and older; severe chronic plaque psoriasis in those 4 and older; enthesitis-related arthritis in children 6 and older; and polyarticular juvenile idiopathic arthritis in those 2 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 a press release. “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.”
Like Humira, Amgevita is a TNF-inhibiting anti-inflammatory biologic medication. It binds to tumor necrosis factor-alpha (TNFα), which normally binds to TNFα receptors, leading to the inflammatory response in autoimmune diseases. By binding to TNFα, the drug reduces the inflammatory response. Amgevita is injected.
A biosimilar is a biological product similar to a medicine. Like the drug on which it is based, it must follow U.S. and EU regulatory guidelines. To be commercialized, a biosimilar must have safety and effectiveness similar to the original product’s. It also must be considerably more affordable and accessible.
Amgevita’s approval was based on clinical trials demonstrating its biosimilarity to Humira. Two Phase 3 clinical trials covered patients with moderate to severe rheumatoid arthritis (NCT01970475) and patients with moderate to severe plaque psoriasis (NCT01970488).
In both studies, Amgevita exhibited the same therapeutic benefits as Humira. It also showed comparable safety and immunogenicity, or the ability to trigger an immune response.
This European Commission approval allows Amgen to market Amgevita in all 28 European Union countries.