The Korea Herald

지나쌤

Samsung BioLogics to produce affiliate’s biosimilars

By Korea Herald

Published : May 3, 2016 - 16:19

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Samsung BioLogics is scheduled to begin producing biosimilar drugs developed by its affiliate Samsung Bioepis, as the two have entered a production partnership, the companies said Tuesday.

Samsung BioLogics confirmed to The Korea Herald that it has “recently sealed a production partnership with Samsung Bioepis.” It declined to offer further details about the deal, including its size and timing, citing regulatory compliance.

The Samsung BioLogics headquarters in Songdo, Incheon (Samsung BioLogics) The Samsung BioLogics headquarters in Songdo, Incheon (Samsung BioLogics)

Samsung Bioepis also acknowledged the deal. “At Samsung Bioepis, we use multiple contract manufacturing organizations, in order to ensure the reliable supply of our products. The addition of Samsung BioLogics provides us with increased capacity,” said company spokesperson Hyun Min-gi.

Founded in 2011, Samsung BioLogics is a contract manufacturer of biologic drugs developed by pharmaceutical companies. Its publicly known clients include Roche and Bristol-Myers Squibbs.

BioLogics currently operates two production plants, with construction underway for its third plant which is scheduled for completion in 2018. Its first plant was approved by the U.S. Food and Drug Administration last year while its second plant, boasting a production capacity of 150,000 liters, is preparing for validation by the U.S. and Europe.

According to industry sources, BioLogics will mostly likely manufacture Bioepis’ two biosimilars that have been approved for sale in Korea -- Brenzys and Renflexis. The former is based on Enbrel (etanercept) and the latter on Remicade (infliximab), both blockbuster rheumatoid arthritis treatments.

Samsung BioLogics holds a 91.2 percent stake in Bioepis as its majority shareholder. The remaining 8.8 percent stake is owned by U.S. pharmaceutical company Biogen, one of Bioepis’ production and marketing partners.

By Sohn Ji-young (jys@heraldcorp.com)