Samsung BioLogics gains U.S. FDA approval

Samsung BioLogics earned approval from the U.S. Food and Drug Administration (FDA) to produce drug products, the company said Wednesday.

The deal follows drug production approvals from the European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency. The biopharmaceutical arm of Samsung is now able to supply drugs to the world’s three biggest markets.

In the biopharmaceutical sector, the manufacturing process is split between the production of drug substances and actual drug products. The former is a complicated procedure that encompasses fermentation, extraction and the combination of substances that serve as raw materials for drugs. Even the last step of putting products into containers, such as vials, requires sophisticated technologies, which makes it challenging for manufacturers to obtain quality certification.

Samsung BioLogics is an unusual global contract manufacturing organization, the company says, able to offer end-to-end services from cell line development to production of drug products.

“Following the approval from the U.S. FDA for our drug products, customers can now have cell lines developed and raw materials and drugs produced all from the same company,” said Kim Tae-han, chief executive officer of Samsung BioLogics, “which will save costs and time and enhance convenience.”

Ever since its initial approval at the end of 2015, the company has earned 12 approvals for drug substances and four for drug products around the world.

Meanwhile, the company reported an earnings surprise on Monday. Revenue in the second quarter rose 98.4 percent year on year to 125.4 billion won ($111.2 million) and operating profit surged 378.8 percent to 23.7 billion won on year, much larger than an average of analysts’ estimates of 17.1 billion won.

An accounting scandal engulfing the company has yet to come to an end, however.

The Financial Services Commission may have to start a second probe to determine whether the company deliberately changed the status of Samsung Bioepis from a subsidiary to an affiliate to increase its valuation.

BY SEO JI-EUN [seo.jieun@joongang.co.kr]