Samsung BioLogics reaches milestone with FDA nod for production of mAb at South Korean plant

South Korea’s quickly growing biologics CDMO, Samsung BioLogics, has won FDA approval for its first finished product at the second of three plants that have been built in rapid succession.  

The company said this week that the FDA had licensed the facility to manufacture a monoclonal antibody but did not identify the product or the client. The plant is already approved by the FDA to make drug substances, and Europe has approved the facility to produce two finished products.

CEO Tae-Han Kim, Ph.D., said in a statement that with the approval, Samsung BioLogics has shown it has end-to-end capabilities.  

The unit of the Samsung conglomerate also reported earnings this week that included a net loss of 9.6 billion won ($8.53 million) in the second quarter. It reported that sales at Plant 2 increased, but total quarterly sales fell 4.3% compared to last quarter on costs of ramping up production for new products at Plant 1. 

It said the operating profit of Samsung BioLogics increased sharply by KRW 13.7 billion ($1.2 million) from the previous quarter and that it showed an improvement in its net loss as sales improved from its Samsung Bioepis subsidiary, a joint venture with Biogen to produce biosimilars.

Earlier accounting at the JV, however, has been called into question by Korean regulators. Earlier this month, South Korea's Securities and Futures Commission found that Samsung BioLogics "violated accounting standards by intentionally omitting information regarding the joint venture agreement with Biogen in its public disclosure." It said it had referred its finding to prosecutors. Samsung has denied the allegations, saying it complied with all accounting standards.

The disclosures came even as Biogen paid about $700 million to increase its share in the JV to 49.9% from 5.4%. Biogen CEO Michel Vounatsos said in the company’s first-quarter earnings call that the biotech decided to up its stake because of the success of the JV. He said the joint venture's European biosimilar revenue is tracking at about $500 million per year.

Samsung has established its CDMO business quickly after deciding it was a viable extension of its chemicals business. It has pledged to become the top biologics contract manufacturer in the world. It is in the process of completing a third biologics plant at a site in Incheon next to two others. All three have been erected in seven years. With completion of the third facility, the company will have total capacity of 362,000 liters. Samsung said it will have invested 3 trillion won, about $2.6 billion, in the massive buildup