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
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.