Samsung BioLogics announced on Wednesday that it has been licensed by the European Medicines Agency (EMA) for the first monoclonal antibody drug substance at its second plant, the world`s largest single biopharmaceutical plant, just two months after manufacturing approval from the U.S. Food and Drug Administration (FDA).

Samsung BioLogics closed up 2.84 percent to 362,500 won ($332.4) on the Kospi market.

Biopharmaceutical plants are subject to regulatory approval for manufacturing a specific product whenever a contract production order is received.

The first license of its second plant from the EMA also represents the shortest time to regulatory approval, breaking a previous record held by its first plant, whose time to the FDA license was 25 months after an initial operation.

Currently, Samsung BioLogics has the production capacity of 180,000 liters through its first plant with 30,000 liters of capacity, which started full commercial operation in November 2015, and second plant with 152,000 liters of capacity, which started operation in February 2016. Once its third plant which was recently completed goes operational, Samsung will be the world’s largest CMO company with 362,000 liters of capacity in total.

Samsung BioLogics won a total of 11 approvals now from FDA, EMA, and PMDA for 15 products from 10 global healthcare companies such as BMS and Roche, the company said.

The amount of 180,000 liters of biopharmaceutical products can cover one in 10 cancer patients around the world.

By Shin Chan-ok and Minu Kim

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