Posted by Michael Wonder on 25 Aug 2017
Samsung Bioepis first to obtain European Commission approval for a third anti-TNF-α biosimilar with Imraldi (adalimumab)
24 August 2017 - Samsung Bioepis today announced the European Commission’s approval of Imraldi, a biosimilar referencing Humira (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis.
The EC approval of Imraldi applies to all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Biogen will commercialise Imraldi in the EU and EEA member states.
