Samsung Bioepis receives European Commission approval for second Anti- TNF-alfa biosimilar Flixabi

Samsung Bioepis Co., Ltd. announced the European Commission’s (EC) approval of Flixabi – a biosimilar version of Remicade (infliximab), also known as SB2 – for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

“With this approval, we are taking another important step in broadening affordable, high-quality biologic treatment options across Europe,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “The focused dedication of everyone at Samsung Bioepis has now yielded in the European approval for another biosimilar referencing a most widely used biologic medicine. Our commitment to quality and speed has brought us this far in just over four years, and our relentless drive for healthcare innovation will continue as we further advance one of the industry’s largest biosimilar pipelines.”

The EC approval of Flixabi applies to all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. In accordance with a commercialization agreement signed in 2013 between Samsung Bioepis and Biogen, Biogen will lead the commercialization and distribution of Flixabi® in the EU and EEA member states.

In a 54-week Phase III clinical study, Flixabi showed comparable safety and equivalent efficacy to Remicade, as evidenced in ACR20 response rate of 65.3% in the Flixabi arm versus 69.2% in the Remicade arm at Week 54, fully supporting the 30-week study results of 64.1% and 66.0%, respectively. The Flixabi study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries.