This EU approval follows a positive opinion granted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in January recommending marketing authorization of Amgevita.
“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, Amgen’s executive vice-president of research and development, 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.”
Amgevita is an anti-TNF-alpha monoclonal antibody with the same structure and action, pharmaceutical dosage form and strength as Humira. It blocks TNF (tumor necrosis factor) pro-inflammatory activity and its induced or regulated immune responses.
A biosimilar is a biological product designed to be very similar to a reference medicinal product, its originator. It must follow EMA guidelines as well as those of the U.S. Food and Drug Administration (FDA). To be commercialized, a biosimilar needs to have achieved similar levels of safety and efficacy as its originator, and should be notably more affordable and accessible.
The EU based its approval of Amgevita on clinical studies showing that the drug’s quality, safety and efficacy was comparable to Humira. Two Phase 3 clinical trials, in patients with moderate to severe plaque psoriasis (NCT01970488), and in patients with moderate to severe rheumatoid arthritis (NCT01970475), provided that evidence.
In both studies, Amgevita demonstrated no differences in terms of therapeutic benefits from Humira. It also showed comparable safety and immunogenicity, or an ability to trigger an immune response.
The European Commission (EC) has also granted marketing authorization for Amgevita as a treatment for adults with psoriatic arthritis, severe ankylosing spondylitis (AS), severe axial spondyloarthritis,moderate to severe rheumatoid arthritis (RA), 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.
In addition, the EC has 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 with ages of 2 and older.
This approval allows Amgen, which is based in Thousand Oaks, Calif., to market Amgevita in all 28 EU member countries as well as in Iceland, Liechtenstein and Norway, which belong to the European Economic Area. In September 2016, the FDA approved the medicine as Amjevita (adalimumab-atto) for psoriasis and other inflammatory conditions.