The European Commission recently announced it has approved the Amgen’s Amgevita, an anti-inflammatory drug, for sale in more than two dozen member nations.
The drug's approval in Europe, as well as its approval in the United States in September, were based on outcomes from clinical trials that studied the medicine’s use in plaque psoriasis, arthritis and Crohn’s disease, among both adult and pediatric populations.
“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," Dr. Sean E. Harper, 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."
Based in Thousand Oaks, California, Amgen will market the injectable drug in the U.S. under the Amjevita label, whereas it will use Amgevita in Europe.
