On Monday, the Seoul Central District Prosecutor’s Office in the Republic of Korea arrested an executive and another employee at biosimilar developer Samsung Bioepis for falsifying and destroying evidence and for violating audit law.
According to the Financial Times and other sources, on Monday, the Seoul Central District Prosecutor’s Office in the Republic of Korea arrested an executive and another employee at biosimilar developer Samsung Bioepis for falsifying and destroying evidence and for violating audit law.
In November 2018, Korean regulators from the Securities and Futures Commission (SFC) said that, in 2015, Samsung BioLogics used accounting methods that allegedly misrepresented the value of the biosimilar maker prior to an initial public offering in 2016.
According to officials, Samsung BioLogics changed the way it accounted for its stake in Samsung Bioepis, a partnership with Biogen, by recognizing the partnership’s market value instead of its book value, thereby inflating its valuation.
According to Korea Biomedical Review, the arrest warrants that were executed this week are the first to be filed in the case and relate to data that may have been deleted from computers and mobile phones.
These data could be relevant, said officials, to determining whether Biogen’s contractual option to increase its share in the Samsung Bioepis partnership to 49.9% was hidden from accountants who were responsible for a merger between Cheil Industries and Samsung in 2015. Biogen announced in 2018 that it would exercise its option.
The arrests are the latest development in the probe that, last year, resulted in a $7.05 million fine, the suspension of Samsung BioLogics’ stock trading, and calls for the firing of the firm’s chief executive officer as well as the chief financial officer.
The company’s stock subsequently resumed trading in December 2018 after officials ruled that the company’s shares could remain listed while the case played out.
Then, in January of this year, a Korean court ruled that penalties against Samsung BioLogics should be suspended pending a final court determination on whether the company had indeed violated accounting standards.
For its part, Samsung BioLogics has maintained that it has not breached any accounting rules. In late 2018, the company launched an administrative lawsuit with the aim of proving the legality of its actions.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD
November 9th 2024A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.