- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
2 Arrested in Samsung Bioepis Accounting Probe
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.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
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.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
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.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
