Amgen has won European approval for its first biosimilar, a version of AbbVie’s blockbuster Humira (adalimumab).
The European Commission has approved Amgevita (biosimilar adalimumab) in all the available indications of its originator product, marking the first European licence for a biosimlar version of Humira
In doing Amgen said it had marketing authorisation for “all available indications” for its biosimilar Humira, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis and moderate-to-severe Crohn’s disease.
Sean Harper, executive vice president of research and development at Amgen, said: “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.
“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.”
The EC approved Amgevita after its scientific advisors concluded the biosimilar was highly similar to Humira, with studies showing it had comparable quality, safety and efficacy to its originator.
Amgen said the data it submitted to the regulators included results from two phase 3 studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. Both met their primary endpoints, showing no clinically meaningful differences to Humira and comparable safety and immunogenicity for Amgevita.
First approved in 2003, Humira last year brought in sales of $16.1 billion for AbbVie.
