Additional drug from Samsung BioLogics 2nd plant gains FDA okay

2018.05.24 13:17:41 | 2018.05.24 15:34:12

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South Korea¡¯s Samsung BioLogics Co., the world¡¯s third-largest contract drugmaker under scrutiny by domestic authorities for an accounting misdeed, gained a boost after its second plant was cleared by the U.S. Food and Drug Administration to supply another drug to the U.S. market.

Since opening in 2016, the second plant, also located at the Songdo Free Economic Zone equipped with 15,000 bioreactors, has won marketing licenses for three products from U.S. and European authorities.

Together with the first plant, the contract drugmaker is licensed to supply 14 drugs to the United States and Europe.

A licensed drug requires separate marketing approval from the host government if there is a change in manufacturing facilities.

The positive news comes on the heels of its U.S. partner Biogen confirming its plan to increase its stake in their biosimilar joint-venture Samsung Bioepis to up to 49 percent from current 5.4 percent by late June, helping to ease investors¡¯ jitters over the accounting probe.

The company is accused of inflating the valuation of Samsung Bioepis before the parent company Samsung BioLogics went public. It maintains it adopted a different accounting standard by switching the status of the joint-venture from subsidiary to affiliate by reflecting Biogen¡¯s increased stake after it exercised call option.

Shares of Samsung BioLogics closed Thursday up 4.63 percent at 418,000 won ($387).

By Shin Chan-ok and Kim Hyo-jin

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