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Samsung Biologics wins manufacturing approval from Europe

All News 11:28 December 13, 2017

By Kim Han-joo

SEOUL, Dec. 13 (Yonhap) -- South Korean biopharmaceutical firm Samsung Biologics Co. said Wednesday it has won approval from European health authorities to manufacture drugs at its plant in Europe.

The European Medicines Agency (EMA) accepted Samsung Biologics' manufacturing application to make 152,000 liters of biosimilars at the plant, officials said.

The approval comes 21 months after the biopharmaceutical unit of South Korea's top conglomerate Samsung Group completed the plant.

"We constructed a system to shorten the approval period so that our customers can receive our products as soon as possible," said Samsung Biologics CEO Kim Tae-han, adding that the company will continue to prove its products are globally competitive.

The company has received a total of 11 manufacturing approvals from the United States, Europe and Japan over the past six years for a combined production capacity of 362,000 liters.

In 2015, Samsung BioLogics won approval for commercial production by the U.S. Food and Drug Administration after a 25-month application process.

To receive manufacturing approval, applicants are required to conduct pilot production and submit the results in accordance with protocols. It usually takes up to three years, but the company shortened the period.

The market for biosimilars has grown in recent years as they are provided to customers at discounts. Biosimilars are officially approved copycat medicines developed after patents for the original biopharmaceuticals expire.


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