INCHEON, Korea, Jan 18 (Bernama-BUSINESS WIRE) -- Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) approval of Benepali® – a biosimilar referencing Enbrel® (etanercept), also known as SB4 – 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 Benepali® by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which was announced on November 20, 2015.
“The approval of Benepali and its subsequent launches in Europe are major milestones for Samsung Bioepis,” said Christopher Hansung Ko, President & CEO 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.”
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