EU approves Flixabi (infliximab biosimilar) to treat indications of the reference product- Remicade.- Biogen

The European Commission (EC) has granted marketing authorization in the European Union (EU) for Flixabi an infliximab biosimilar referencing Remicade . FlixabiI was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen. Flixabi is indicated for the treatment of adults with rheumatoid arthritis (RA), Crohn�s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

Additionally, Flixabi can be used in patients 6 to 17 years old with severe, active Crohn�s disease or severely active ulcerative colitis. Flixabi will be the second anti-TNF biosimilar to be manufactured and commercialized by Biogen in the EU. Earlier this year, Samsung Bioepis received approval for Benpali (etanercept), a biosimilar referencing Enbrel. Biogen has since launched Benpali in several countries across the EU. At an estimated $10Bn a year, anti-TNF therapies are among the EU�s largest drug expenditures. Benpali and Flixabi will offer physicians alternatives that will drive meaningful savings across the EU.