Canada OKs Samsung BioLogics’ mAb Drug Substance Plant

Samsung BioLogics, a contract development and manufacturing organization (CDMO) announced on June 21, 2018 that Health Canada has licensed its first plant in Icheon, South Korea, to manufacture a monoclonal antibody drug substance.

Health Canada’s approval marks the second drug product approval and third global approval for Samsung BioLogics, following approvals from FDA, European Medicines Agency, and Pharmaceuticals and Medical Devices Agency in Japan. Samsung BioLogics has received a total of 14 global manufacturing approvals for 14 biologics products. The company expects to reach a total of 30 approvals from global regulatory agencies within 2018.

“Samsung BioLogics has grown rapidly during the last seven years with 14 global regulatory agency approvals and 362,000 liters biologics manufacturing capacity,” said TH Kim, CEO and president of Samsung BioLogics, in a company press release. “We will change the paradigm of the bio industry with innovation and ultimately benefit the patients by providing the biologics drugs in a timely manner at lower cost.”

Source: Samsung BioLogics