Samsung Bioepis enters European market with Benepali, first Enbrel biosimilar

The European Commission has approved Benepali – a biosimilar referencing Enbrel (etanercept) – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis.

The EC approval follows a positive opinion on Benepaliby the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which was announced on November 20, 2015. Samsung Bioepis is a joint venture between US biotech firm Biogen (Nasdaq: BIIB) and South Korea’s Samsung Bioepis, and Benepali, a biosimilar of Amgen and Pfizer’s immunology drug.

“The approval of Benepali and its subsequent launches in Europe are major milestones for Samsung Bioepis,” said Christopher Hansung Ko, president and chief executive of Samsung Bioepis, adding: “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.”