EMA Committee Recommends Approval of Amgen's Adalimumab Biosimilar

Amgen’s biosimilar adalimumab (ABP 501), a biosimilar of AbbVie’s Humira, has received a positive opinion regarding marketing from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The active ingredient of ABP 501 is an anti-tumor necrosis factor (TNF)-alpha monoclonal antibody that has the same amino acid sequence as adalimumab. The decision is the first time an adalimumab biosimilar has been recommended for approval in the European Union (EU). ABP 501, branded as Amjevita (adalimumab-atto) in the United States, was approved by the FDA in September 2016. However, Amjevita has not yet been marketed in the US because AbbVie sued Amgen for patent infringement and the litigation is still in process.

ABP 501 was recommended for approval for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis (RA), psoriatic arthritis, severe ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe plaque psoriasis, moderate-to-severe hidradenitis suppurativa, noninfectious intermediate, posterior and panuveitis, moderate-to-severe Crohn’s disease, and moderate-to-severe ulcerative colitis. The CHMP also recommended approval for the treatment of certain pediatric inflammatory diseases, including moderate-to-severe Crohn’s disease (ages 6 and older), severe chronic plaque psoriasis (ages 4 and older), enthesitis-related arthritis (ages 6 and older) and polyarticular juvenile idiopathic arthritis (ages 2 and older).

The CHMP’s positive opinion will be reviewed by the European Commission, which is authorized to approve medicines for the EU. The process typically takes approximately 60 days. If approved, ABP 501 will receive a centralized marketing authorization that is valid for the 28 countries in the EU. Norway, Iceland, and Liechtenstein, members of the European Economic Area, will make corresponding decisions on the basis of the EC’s decision.