Amgen Gains EC Approval for Biosimilar to Adalimumab

Amgen has gained a European marketing authorization for its biosimilar version of Abbvie’s anti-inflammatory drug adalimumab (Humira), making it the first European license for a biosimilar to adalimumab. Amgen’s product will be called biosimilar adalimumab (Amgevita).

Biosimilar adalimumab is approved for the following inflammatory conditions in adults:

• 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

It is also approved for the following pediatric conditions:

• 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)
• Polyarticular juvenile idiopathic arthritis (ages 2 and older)

The approval comes from results of 2 phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients, each of which met their primary endpoint with no clinically meaningful differences to adalimumab, including safety and immunogenicity data.

Approval from the European Commission (EC) means Amgen can now market the drug across 28 countries across Europe. Other European Economic Area member nations, including Norway, Iceland and Liechtenstein, will take corresponding decisions based on the EC decision.

Called adalimumab-atto (Amjevita) in the United States, Amgen gained FDA approval in September 2016. However, pending legal issues have prevented market launch.

Global sales of Humira crossed $16 billion in 2016.