In a 52-week Phase III study, Benepali demonstrated comparable safety and equivalent efficacy to Enbrel, with a ACR20 response rate of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm.
Benepali will be marketed across all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Under a commercialization agreement signed in 2013, Biogen will lead the commercialization and distribution of Benepali in the EU and EEA member states.
“The approval of Benepali and its subsequent launches in Europe are major milestones for Samsung Bioepis,” said Christopher Hansung Ko, president and chief executive officer of Samsung Bioepis. “In just under four years, we successfully developed, tested and obtained regulatory approval for Benepali, a high-quality biologic medicine that will drive down healthcare costs and increase patient access to one of the most widely used treatment options for immunological diseases across Europe.”