EU Commission approves Amgevita (biosimilar adalimumab) for all indications of the originator drug.- Amgen.

Amgen has announced that the European Commission (EC) has granted marketing authorization for Amgevita (biosimilar adalimumab) in all available indications. Amgevita is authorized for the treatment of certain inflammatory diseases in adults, 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 the treatment of 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).

Comment: The EU patent for Humira (adalimumab) expires in April 2018. The US patent is expected to go on until 2022.