- Samsung BioLogics can now boast regulatory approval from both EU and U.S. agencies of its biologics production facility in Incheon, Korea, announcing Wednesday the European Medicines Agency had licensed its new manufacturing site.
- Plant No. 2, as it's known, lists 150,000 liters of production capacity and 10 bioreactors — five times larger than Samsung's first plant, the company said.
- The Food and Drug Administration licensed Plant No. 2 two months ago, just 19 months after operations first began on the site.
Samsung BioLogics is quickly ramping up its production capacity. With Plant No. 2 now licensed by the EMA and FDA; Samsung has a total of 180,000 liters of capacity certified by regulators.
Another facility, Plant No. 3, was recently completed and will add another 180,000 liters to Samsung's current base. When all online together, the Korean drugmaker says it will be the world's largest contract biologics manufacturer.
For Plant No. 2, FDA and EMA inspections overlapped, helping bring down the total time Samsung needed to secure licensure for the facility.
Although a relatively newer competitor, Samsung BioLogics aims to be a leader in the biologics contracting space, and has secured 15 product manufacturing orders from 10 pharmaceutical companies.
The company has also invested with Biogen Inc. in a joint venture called Samsung Bioepis, which has dedicated its efforts to date at developing new biosimilars — though it plans to soon branch into novel drug development of biologics.