Samsung Bioepis receives clinical trial suspension for violation of MFDS regulatory requirements

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The Korean Ministry of Food and Drug Safety (MFDS) has imposed an administrative penalty on Samsung Bioepis for violating regulatory requirements in conducting a clinical study. This penalty is equal to a 1.5-month suspension of clinical trials for SB15-3001, an aflibercept biosimilar for neovascular age-related macular degeneration (nAMD).¹

The violation occurred when Samsung Bioepis reportedly altered the approved validity period of the clinical trial drugs without obtaining the required modification approval from the MFDS. The company also deviated from the approved labeling requirements. These actions violated the Pharmaceutical Affairs Act, suspending clinical trial operations until Tuesday, February 2, 2024.¹

According to the source article¹ in the Korea Biomedial Review, a Samsung Bioepis official said that the clinical trial had already concluded, and that the administrative penalty would not have an impact. The official is quoted as saying, “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.”

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.¹

Reference:

1. Regulator suspends clinical trial of Samsung Bioepis' Eylea biosimilar for misconduct. Korea Biomedical Review. December 18, 2023. Accessed December 21, 2023. https://www.koreabiomed.com/news/articleView.html?idxno=22812