South Korea’s Samsung Biologics is fast building credential as an out-licensing manufacturer of new drugs, having received a series of regulatory approvals from health authorities in the U.S. and Europe over the recent month.

The company said on Wednesday that it received six additional approvals - two from the U.S. Food and Drug Administration (FDA) and four from the European Medicines Agency (EMA). As a result, it now has seven licenses to manufacture drugs.

Manufacturing biologics requires challenging processes and product safety is directly related to the safety of consumers. The U.S. and Europe account for more than 80 percent of the global biologics market and their regulatory requirements are very rigorous. To receive manufacturing approval, applicants are required to conduct self-validation and pilot production and submit the results according to protocols. It usually takes as long as three years to complete these procedures, but Samsung Biologics dramatically shortened the period.

The latecomer, which started contract manufacturing organization (CMO) business for biologics makers in 2011, has been accelerating efforts to catch up with global players.

Samsung’s unique technology in plant engineering was employed to maximize production capability while reducing the budget and time for construction. The company also achieved the approval of manufacturing ahead of schedule by applying multiple products at once with multiple authorities, which led to long-term contracts with global pharmaceutical companies such as Roche and BMS, the company said.

In 2018, when its third plant is completed, total production capability will jump to 360,000 liters, making the company the largest CMO in the world.

The company’s first plant with production capacity of 30,000 liters achieved the milestone of generating operating profit for the first time this year. With growing commercial production, revenue in the first six months is estimated to surpass 130 billion won ($119 million_, much higher what it generated in 2015.

By Shin Chan-ok and Lee Dong-in

[ⓒ Pulse by Maeil Business News Korea & mk.co.kr, All rights reserved]