Samsung BioLogics wins first FDA approval for drug products

Samsung BioLogics wins first FDA approval for drug products. July. 26, 2018 07:33. by Seong-Ho Hwang hsh0330@donga.com.
Samsung BioLogics has obtained its first approval from the U.S. Food and Drug Administration (FDA) to produce drug products, gaining a foothold in the contract manufacturing organization (CMO) market. The company also has been licensed to produce drug products in Europe and Japan. A drug product refers to drug substance that is packaged in a vial, which is the process conducted in the final production stage.

Samsung BioLogics said Wednesday that a company, which requested contract manufacturing to Samsung BioLogics, won FDA approval for drug products at the end of last month. The drug product will be manufactured at the South Korean pharmaceutical company’s Plant 1 located in Yeonsu-gu, Incheon. One of the key business models of Samsung BioLogics is CMO.

By winning the approval, Samsung BioLogics now has a license to manufacture drug products in three key biopharmaceutical markets in the world: the United States, Europe, and Japan. The South Korean pharmaceutical company won approval for drug products from the European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency in June 2016 and May 2017, respectively.

“Samsung BioLogics continues to prove that it possesses the capability to provide end-to-end service from cell line development to fill and finish DP service,” Samsung BioLogics CEO Kim Tae-han said. With the FDA approval, the Korean biotech drug manufacturer has so far obtained a total of 16 global approvals, including approvals for four drug products and 12 drug substances.