FDA Approves Drug Product Manufacturing for Samsung BioLogics

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

Samsung BioLogics announced on July 25, 2018 that it has been licensed by FDA to manufacture a monoclonal antibody drug product at its Songdo Plant 1. The company has 16 global approvals for manufacturing drug substance in Plant 1 and 2, and drug products in Plant 1 including two European Medicines Agency drug product approvals and one Pharmaceuticals and Medical Device Agency (Japan) drug product approval. 

In a statement announcing the FDA approval, Samsung BioLogics reported the company expects additional global drug substance and drug product approvals for both Plant 1 and Plant 2 during the second half of 2018.

Source: Samsung Biologics