Biogen Gets EU OK for Biosimilar of J&J’s Remicade
The European Commission (EC) has granted marketing authorization in the European Union (EU) for Flixabi, an infliximab biosimilar referencing Johnson & Johnson’s Remicade.Flixabi was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, and 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 Benepali(etanercept), a biosimilar referencing Enbrel. Biogen has since launched Benepali in several countries across the EU.
In May 2016, Samsung Bioepis Co., Ltd. reported that the US Food and Drug Administration (FDA) accepted for review the company's biologics license application (BLA) for SB2, a biosimilar candidate referencing Remicade (infliximab), for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the US. If approved, the marketing and distribution of SB2 in the US will be handled by Merck & Co., in accordance with a commercialization agreement signed in 2013.
Remicade is marketed by Johnson & Johnson’s Janssen Biotech, Inc., based in Horsham, Pennsylvania. Remicade was one of Johnson & Johnson’s top-selling pharmaceuticals with global 2015 sales of $6.56 billion.