Samsung Bioepis Gets EU Approval

Samsung Bioepis Co., Ltd., announced on Sunday that it has received the European Commission’s (EC) approval for Benepali,® a biosimilar arthritis drug Enbrel® (etanercept), also called SB4.

The biosimilar drug is primarily used for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis as well as non-radiographic axial spondyloarthritis) and also plaque psoriasis. This approval follows an optimistic opinion on Benepali® by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) that was revealed on November 2015.

Samsung Bioepis Co., Ltd. centers on advancing as well as commercializing biopharmaceutical and biosimilar products. Its biosimilar product pipeline includes SB4, an etanercept; SB2, an infliximab; SB3, a trastuzumab; SB5, an adalimumab; and SB9, insulin glargine that are in Phase III clinical trials. The company has research, development, manufacturing, and commercialization partnership with Biogen in the areas of immunological disorder; and research, development, and commercialization partnership with Merck. The company is headquartered in Incheon, South Korea.

The approval happens as Samsung Bioepis Co., the firm’s drug development arm, is getting ready for a public listing on the Nasdaq Stock Market. Christopher Hansung Ko, President and CEO of Samsung Bioepis said that the approval of Benepali and its subsequent launches in Europe are major milestones for the company.

“In just under four years, we successfully developed, tested and obtained regulatory approval for Benepali," the CEO notes. "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.”

In a recent statement, the South Korean company said that the EU’s approval, according to reports, is Samsung Bioepis’s first in a major market. Samsung Bioepis has a deal with Cambridge, Mass.-based Biogen Inc to market the Samsung biosimilar in Europe, where it will be sold under the name Benepali, and will be rolled out gradually throughout the 28 European Union member states as well as in Norway, Iceland and Liechtenstein.

Samsung Bioepis is also planning to get regulatory approval for the biosimilar from the U.S. Food and Drug Administration. The biosimilar drug won approval from the South Korean regulators and went on sale last year in partnership with MSD Korea Ltd., a subsidiary of Merck & Co., where it is sold as Brenzys.