30 May 2016 - Biogen to manufacture and commercialize Flixabi, the company’s second anti-TNF biosimilar therapy in the EU.

The European Commission (EC) today granted marketing authorization in the European Union (EU) for Flixabi, an infliximab biosimilar referencing Remicade. Flixabi was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen.

Flixabi is indicated for the treatment of adults with rheumatoid arthritis, 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 Benepali (etanercept), a biosimilar referencing Enbrel. Biogen has since launched Benepali in several countries across the EU. At an estimated $10Bn a year, anti-TNF therapies are among the EU’s largest drug expenditures. Benepali and Flixabi will offer physicians alternatives that will drive meaningful savings across the EU.

For more details, go to: http://media.biogen.com/press-release/biosimilars/flixabi-biogens-infliximab-biosimilar-referencing-remicade-approved-europe