European Commission approves Amgevita (biosimilar adalimumab) for the treatment of certain inflammatory diseases

Amgen

23 March 2017 - First biosimilar adalimumab approved in the European Union.

Amgen today announced that the European Commission has granted marketing authorisation for Amgevita (biosimilar adalimumab) in all available indications. Amgevita is authorised 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 European Commission also approved Amgevita for the treatment of certain paediatric 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).

Read Amgen press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Outcome , Medicine , Europe , Biosimilar