The Ministry of Food and Drug Safety (MFDS) said it imposed an administrative penalty equivalent to a 1.5-month suspension of clinical trials on Samsung Bioepis for violating regulatory requirements in conducting a clinical study.
The clinical trial, "SB15-3001," was aimed to compare the efficacy, safety, pharmacokinetics, and immunogenicity of SB15, an Eylea (ingredient: aflibercept) biosimilar. The original drug treats neovascular age-related macular degeneration.
The ministry stressed Samsung Bioepis reportedly altered the approved validity period of the clinical trial drugs without obtaining the required modification approval from the MFDS. It added that the company also deviated from the approved labeling requirements.
As a result of violating the Pharmaceutical Affairs Act, the ministry said the company's clinical trial operations will be suspended from Tuesday until Feb. 2, 2024.
Regarding the administrative penalty, a Samsung Bioepis official told Korea Biomedical Review that as the clinical trial had already concluded, the administrative penalty would not have any impact.
"The clinical trial ended in April, so the administrative penalty does not affect the clinical trial itself," he said. "We would like to emphasize that the issue is unrelated to product quality. It arose due to differing interpretations between Samsung Bioepis and the regulatory authority regarding the conduct of clinical trials in line with global licensing standards."
Samsung Bioepis presented an interim phase 3 study result that demonstrated SB15's similar efficacy, safety, immunogenicity, and pharmacokinetics (PK) to the original drug during the 2023 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO 2023) in April.
Eylea is a blockbuster ophthalmic drug developed by Regeneron and treats wet age-related macular degeneration and diabetic macular edema (DME). The substance patent was likely to expire in June 2023 in the U.S. and in May 2025 in Europe. The drug had sales of about $9.7 billion worldwide last year.