[THE INVESTOR] Samsung BioLogics, a contract drug maker, said on July 24 that it has obtained approval from the US Food and Drug Administration to manufacture a finished drug product.
This is the first time that the Incheon-based company has received the green light from the US drug regulator for a finished product, though it has been granted similar licenses in the EU and Japan.
“With the FDA approval, Samsung BioLogics will be able to offer end-to-end services from cell culture development to drug substance and finished products, thereby increasing the convenience of clients and greatly reducing their time and costs,” CEO Kim Tae-han said in a statement.
The company did not disclose the name of the product or the company that outsourced the services due to client confidentiality.
The move is in line with Samsung BioLogics’s strategy to widen the range of services and customer base from pharmaceutical companies to small biotech firms and turn around its consecutive quarters of losses. Last year, the company announced it would add contract drug development services to its business portfolio that was focused on contract manufacturing of biopharmaceutical products.
The Samsung unit has received 16 approvals for 12 drug substances and four drug products from global health authorities in less than three years since the first license it obtained in late 2015.
Manufacturing a drug product requires complex and sophisticated technology as it includes the process of packing drug substance into vials. “Health regulators’ review of applications for drug products is quite thorough. Many companies face difficulties to get approval,” a company official said.
On July 24, Samsung BioLogics posted a net loss of 9.6 billion won (US$8.53 million) in the second quarter, up 83.2 percent compared to the earlier quarter on the back of increased production at its second plant.
“The company is quickly strengthening its competitive edge by securing licenses from global regulators to manufacture commercial biologics drug products. It has also increased the number of outsourcing orders for biologic contract manufacturing and development services in the second quarter,” said Hong Ka-hye, an analyst at Daishin Securities.
By Park Han-na (firstname.lastname@example.org)