Samsung BioLogics approved to make first mAb for US market
The US Food and Drug Administration’s (FDA) approval for Samsung BioLogics to create a complete drug product, a monoclonal antibody (mAb), is the first such approval the company has received from the authority. It joins an earlier approval by Japan’s Pharmaceuticals and Medical Devices Agency for a single drug product and two drug product approvals by the European Medicines Agency.
Samsung BioLogics did not reveal the name of the product that will be manufactured, nor its client, but the decision follows on from the FDA’s first approval of the production of a mAb drug substance, in February 2017.
TH Kim, CEO and President of Samsung BioLogics, said in a statement: “Samsung BioLogics continues to prove that it possesses the capability to provide end-to-end service from cell line development to fill/finish DP service…Samsung BioLogics will keep innovating ourselves to manufacture high-quality biologics products for clients all over the world in a timely manner”.
The contract development and manufacture organisation (CDMO) is now building a roster of substances and products it can produce across its two sites, with a third site completed but not yet validated. It has a total of 16 global approvals for drug substances and is rapidly growing its manufacturing base.
However, despite the good news of the approval, there is still an accounting probe hanging over the company. The most serious charge against the company, on the breach of accounting rules, has been delayed until South Korea’s Financial Supervisory Service has produced an audit report.
At the time of publishing, Samsung BioLogics had not replied to correspondence requesting comment.
