Samsung Bioepis will soon be able to export biosimilar drugs in large quantities by investing more than 1 trillion won this month to build the world's largest contract manufacturing plant in Songdo, Incheon.
The Samsung Group company said on November 22 that its SB4 (trade name in Europe "Benepali"), a biosimilar for rheumatoid arthritis drug Enbrel, was given a positive opinion for market approval from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency.
Once such an opinion is out, it usually takes two to three months until official approval. It is expected that the biosimilar drug will be marketed in Europe's 31 nations including Germany from early next year.
In response to the rising demand, Samsung Biologics, the largest shareholder to Samsung Bioepis with a 90.3-percent stake, will build a third plant with an annual capacity of 180,000 liters. Currently the company runs two plants in Songdo, each with an annual capacity of 30,000 liters and 150,000 liters. The second plant, completed in February this year at the cost of 800 billion won, is the world's largest biosimilar facility. Including the third one which will have a 180,000-liter capacity, the company will be able to produce 360,000 liters of the biosimilar drug in a year.
