Amgen Gains European Approval for Biosimilar to AbbVie’s Humira
Amgen has received marketing authorization from the European Commission (EC) for Amgevita (adalimumab), a biosimilar to AbbVie’s Humira (adalimumab), in all available indications. Humira is AbbVie’s top-selling drug with 2016 sales of $16 billion.
Amgen’s Amgevita is authorized in the European Union (EU) for treating certain inflammatory diseases, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; severe active ankylosing spondylitis (AS); 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 also approved Amgevita for treating certain pediatric inflammatory diseases, including moderate-to-severe Crohn’s disease (ages six and older); severe chronic plaque psoriasis (ages four and older); enthesitis-related arthritis (ages six and older); and polyarticular juvenile idiopathic arthritis (ages two and older).
Approval from the EC 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, will take corresponding decisions on the basis of the decision of the EC.
Amgen also has a second biosimilar adalimumab product, which is marketed under the brand name Amjevita (adalimumab-atto), in the US and which was approved by the US Food and Drug Administration in September 2016. Amjevita is currently not available commercially.
In the US, Amjevita is indicated for treating active ankylosing spondylitis; moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and moderate to severe chronic plaque psoriasis. In the US, it is also indicated alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs for treating moderately to severely active rheumatoid arthritis and active psoriatic arthritis. Amjevita is also indicated alone or in combination with methotrexate for treating moderately to severely active polyarticular juvenile idiopathic arthritis.