The European Commission has approved Amgen’s biosimilar version of AbbVie’s $16.1bn-a-year autoimmune disease treatment Humira (adalimumab).
Amgevita (biosimilar adalimumab) is both Amgen’s first biosimilar and now the first Humira biosimilar to be approved in Europe.
The firm said it had won marketing authorisation for “all available indications” for its biosimilar, a list that include 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 within the CHMP ruled that the biosimilar was highly similar to Humira, based on studies showing it had comparable quality, safety and efficacy to the originator.
The data submitted to the regulator included results from two phase 3 studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. Both studies met their primary endpoints and showed no clinically meaningful differences to Humira and comparable safety and immunogenicity for Amgevita.
Amgen’s Humira biosimilar was approved last September in the US under the brand name Amjevita (adalimumab-atto), whose non-proprietary name follows January biosimilar guidance from the FDA for the need for an additional suffix.
Meanwhile, in Europe Amgen’s new product has a duplicate marketing authorisation under the brand name Solymbic.