Samsung BioLogics obtains first US FDA approval for finished drug production

South Korean contract drug manufacturer Samsung BioLogics said Wednesday that it has been licensed for the first time by the US Food and Drug Administration to manufacture a monoclonal antibody drug product in its fully-packaged format at its first plant.

The FDA approval signifies that the given drug product manufactured at Samsung BioLogics can now be sold in the US market.

Biologics production comes in two main formats: drug substance and drug product. The former refers to the drug substance in its raw form, while the latter refers to the drug that is packaged and sealed in a vial.

Quality control and certification standards for drug product manufacturing are considered much more difficult, as the fill and finish process has to be conducted in a pure setting, without pollutants, the company said.

In addition to the US FDA, the European Medicines Agency as well as Japan’s Pharmaceuticals and Medical Devices Agency have also granted drug product approvals to Samsung BioLogics.

“Samsung BioLogics continues to prove that it possesses the capability to provide end-to-end service from cell line development to fill and finish DP service,” Samsung BioLogics CEO Kim Tae-han said in a statement.

“Samsung BioLogics will keep innovating itself to manufacture high quality biologics products for clients all over the world in timely manner,” he said.

By Sohn Ji-young (jys@heraldcorp.com)