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Samsung BioLogics scores certification from US FDA, EMA
By Sohn Ji-youngPublished : Sept. 7, 2016 - 15:02
Samsung BioLogics, a contract manufacturer of biologic drugs under South Korean electronics giant Samsung Group, said Wednesday that it has obtained six manufacturing certifications for biologic drugs produced at its first plant in Songdo, Incheon.
Three monoclonal antibody drugs manufactured by Samsung BioLogics on behalf of its two clients Roche and Bristol-Myers Squibb were approved by the European Medicines Agency in July, the Korean biopharma CMO said.
Of the three products, two were newly approved by the US Food and Drug Administration last month, in addition to the one product which was already approved by the US FDA in October last year.
The EMA has also certified the drug packaging product made by Samsung in addition to its three drugs, it added.
The given certifications allow Samsung’s two clients to commercialize the three drugs in the US and Europe, the world’s two top markets for biologic drugs, Samsung Biologics told The Korea Herald.
Due to quality control issues, biopharmaceuticals which were initially approved in a given market -- such as Roche and BMS’ three products -- must be re-certified when produced in another country.
“We are eager to maintain and further improve our biopharmaceutical quality systems and manufacturing process in a Good Manufacturing Practice-certified manufacturing facility to provide high-quality products to our clients,” Samsung BioLogics CEO Kim Tae-han said in a statement.
“We can expect and are prepared to receive more inspections from various other regulatory agencies such as those in Japan, Russia and so on this year,” Kim said.
Founded in 2011, Samsung BioLogics is a contract manufacturer of biologic drugs developed by global pharmaceutical companies. It stands at the center of Samsung Group’s recent push in the biopharma business, considered a lucrative industry to propel the conglomerate’s future growth.
The Samsung unit currently operates two high-tech biologics manufacturing plants boasting a combined production capacity of 180,000 liters, the third-largest in the world.
The second plant began test operations from this March, and must wait for around 1 1/2 years to two years before it can apply for certification from the FDA and EMA, Samsung BioLogics said.
The Korean biopharma CMO is currently building its third plant, which upon its scheduled completion in 2018 will drive up the firm’s net capacity to 360,000 liters, leapfrogging current segment leaders Lonza (260,000 liters) and Boehringer Ingelheim (240,000 liters).
Samsung BioLogics plans to continue adding more production plants, using the new capital to be generated by its initial public offering on the Kospi scheduled for the end of this year.
By Sohn Ji-young (jys@heraldcorp.com)
