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Samsung Bioepis Faces Administrative Penalty for Clinical Study Violation

Samsung Bioepis Faces Administrative Penalty for Clinical Study Violation

December 27, 2023

In a recent development, the Korean Ministry of Food and Drug Safety (MFDS) has levied an administrative penalty against Samsung Bioepis for non-compliance with regulatory requirements during a clinical study. The penalty equates to a 1.5-month suspension of clinical trials for SB15-3001, an aflibercept biosimilar designed for neovascular age-related macular degeneration (nAMD).

The violation stemmed from Samsung Bioepis allegedly modifying the approved validity period of the clinical trial drugs without securing the necessary modification approval from the MFDS. Additionally, the company deviated from the approved labeling requirements, leading to a suspension of clinical trial operations until Tuesday, February 2, 2024, in accordance with the Pharmaceutical Affairs Act.

According to statements reported by the Korea Biomedical Review, a Samsung Bioepis official asserted that the clinical trial concluded in April, and the administrative penalty would not impact its outcome. The official clarified, stating, "The clinical trial ended in April, so the administrative penalty does not affect the clinical trial itself. 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."

Notably, Samsung Bioepis presented interim Phase 3 study results at the 2023 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO 2023) in April. These results showcased SB15's comparable efficacy, safety, immunogenicity, and pharmacokinetics (PK) in relation to the original drug. The company remains committed to upholding global standards in clinical trial conduct despite the regulatory setback.



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