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Samsung BioLogics’ plant No. 2 wins FDA approval

South Korean biopharma company Samsung BioLogics has won approval from the US Food and Drug Administration for bio drugs manufactured from its second plant in Songdo, west of Seoul, the company said Thursday.

(Yonhap)
(Yonhap)


Winning the FDA’s approval means that the company can sell bio drugs manufactured from its second plant in the United States, according to the company. It also indicates that the firm has gotten the greenlight to manufacture a new bio product at the second factory, as companies have to get the approval of the FDA -- or similar state agencies depending where the product is headed -- for new products.

An official said that the company is going to produce an original bio product, not a biosimilar, but declined to name the client and product, citing confidentiality.

The company already received 13 approvals from the FDA and the European Medicines Agency. The second factory acquired three approvals in the 26 months since it began operation. The factory is capable of producing 150,000 liters of bio products.

Samsung BioLogics is a contract manufacturing organization that produces biologics on the request of global drugmakers.

By Cho Chung-un (christory@heraldcorp.com)
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