While Facing Sanctions, Samsung Ups Its Investment in Biologics

This week, Samsung, the parent company of Samsung BioLogics and biosimilar development company Samsung Bioepis, announced plans to invest $22 billion across business lines including biopharmaceuticals.

“For biopharmaceuticals, Samsung has seen strong growth from both its contract manufacturing and biosimilar businesses. It will continue to invest heavily in the businesses, including developing and manufacturing biosimilars to combat chronic and difficult-to-cure diseases,” read the statement.

Samsung has already taken an active role to further invest in its biosimilar business with the creation of a new manufacturing plant in Songdo, Incheon, Republic of Korea, its third in this location. With the completion of this plant, the company will have the total production capacity of 362,000 liters and will have invested $2.6 billion (3 trillion won), in manufacturing capabilities. Commercial production is expected to begin at this plant in 2020.

Click here to read more about Samsung Bioepis.

Though the production capabilities of the company have increased, last month, Samsung BioLogics reported earnings that included a net loss of $8.53 million (9.6 billion won) in the second quarter. It also reported that the operating profit of the company increased by $1.2 million (13.7 billion won) from the quarter prior and showed improvement in its net loss, as sales had improved from its Samsung Bioepis subsidiary, a joint venture with Biogen.

Accounting practices at Samsung BioLogics were recently called into question, however, when South Korea’s financial regulator, the Securities and Futures Commission (SFC), found that Samsung BioLogics had not disclosed that Biogen had the option to increase its stake in the joint venture with Samsung Bioepis to 49.9%.

“The SFC concluded that Samsung BioLogics had violated accounting standards by intentionally omitting information regarding it joint venture agreement with Biogen in its public disclosure,” read the announcement from the SFC.

The agency has mandated sanctions against Samsung BioLogics including a request for dismissal of executives in charge, designation of external auditors for the next 3 years, and referral to prosecutors. Additionally, the company’s current auditor would be barred from auditing the company for 4 years and would also be referred to prosecutors for violation of auditing standards.

Just last month, the FDA granted Samsung BioLogics approval for its first completed monoclonal antibody at the first of its 3 plants. The product nor the client it was manufactured for were disclosed.