A South Korean court ruled this week that penalties imposed against Samsung BioLogics, parent company of biosimilar developer Samsung Bioepis, by the Financial Services Commission (FSC) for allegedly committing fraud have been suspended.
A South Korean court ruled this week that penalties imposed against Samsung BioLogics, parent company of biosimilar developer Samsung Bioepis, by the Financial Services Commission (FSC) for allegedly committing fraud have been suspended.
In November, the Nikkei Asian Review reported that the FSC had found that, in 2015, Samsung BioLogics had used accounting methods that allegedly inflated the value of the company prior to an initial public offering in 2016.
The FSC imposed penalties including an estimated $7.05 million fine, suspended Samsung BioLogics’ stock trading, and called for the firing of the firm’s chief executive officer, Kim Tae-han, as well as the chief financial officer.
The company’s stock subsequently resumed trading in December 2018 after the exchange ruled that the company’s shares could remain listed while the case played out.
Upon the alleged fraud being made public, Samsung Biologics sent a letter to its shareholders apologizing for any confusion caused by the “recent accounting issue,” and went on to say that the “[Securities and Futures Commission]’s announcement is very unfortunate as it is our firm belief that Samsung BioLogics has not breached any accounting rules at all.”
In fact, the company indicated that it had sought the advice of multiple accounting firms, all of whom deemed its accounting practices acceptable. The auditors who advised Samsung BioLogics were also sanctioned by the commission by way of fines and barring the agencies from auditing Samsung BioLogics for up to 5 years.
Samsung BioLogics then filed an administrative lawsuit at the Seoul Administrative Court seeking to nullify the commission’s findings as well as calling for an injunction to stop any disciplinary action until the court rules on the case.
“The court concluded that an immediate sanction on the company could lead to irreparable damage when its violation of accounting standards has yet to be proven in court,” said an unidentified court official, according to Reuters.
The FSC has stated that it will review the details of the courts findings and plan whether to file an immediate appeal. Samsung BioLogics, for its part, has maintained its innocence. “The court’s decision is fortunate. We will do our best to prove the legitimacy of the company’s handling of accounting,” said a Samsung BioLogics official.
Samsung now awaits the outcome of the prosecutors’ investigation.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.