The approval follows a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
In a phase 3 clinical trial, Benepali showed comparable safety and equivalent efficacy to Enbrel, as found in ACR20 response rate of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm.
Under the study, 596 patients with moderate to severe rheumatoid arthritis were randomized in spite of methotrexate therapy across 70 sites in 10 countries.
Biogen will lead the commercialization and distribution of Benepali in the 28 EU member states apart from Norway, Iceland and Liechtenstein.
Samsung Bioepis president & CEO Christopher Hansung Ko said: "The approval of Benepali and its subsequent launches in Europe are major milestones for 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."
Samsung Bioepis is also developing biosimilars of other drugs such as Remicade, Humira, Herceptin and Lantus.