January 28, 2023
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Amgen gets European approval for biosimilar of Humira


Thousand Oaks-based Amgen has announced that the European Commission has granted marketing authorization for Amgevita, a drug that treats inflammatory diseases, including moderate-to-severe rheumatoid arthritis.

The Amgen biosimilar will compete with AbbVie’s blockbuster drug Humira.

“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,” said Dr. Sean E. Harper, executive vice president of research and development at Amgen. “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 drug also treats psoriatic arthritis; severe active ankylosing spondylitis; severe axial spondyloarthritis without radiographic evidence of AS; moderate-to-severe chronic plaque psoriasis; moderate-to-severe hidradenitis suppurativa; non-infectious intermediate, posterior and panuveitis; moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis.

The EC approval grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will make corresponding decisions on the basis of the decision by the EC.

Amjevita was approved for sale in the United States by the Food and Drug Administration on Sept. 23.

• Contact Joshua Molina at jmolina@pacbiztimes.com.