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MFDS Suspends Samsung Bioepis’ Concluded Clinical Trials of SB15 Biosimilar to Regeneron’s Eylea® (aflibercept)

Dec 18, 2023

Korea Biomed reported that the Ministry of Food and Drug Safety (MFDS) has imposed a six week suspension of Samsung Bioepis’ completed clinical trials of SB15, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the report Samsung Bioepis altered the approved validity period of the clinical trial drugs without obtaining approval from the MFDS, and deviated from the approved labelling requirements.  The MFDS confirmed Samsung breached the Pharmaceutical Affairs Act and invoked a suspension of the clinical trial until 2 February 2024, despite the clinical trials having already concluded.

On 7 October 2023, Samsung Bioepis announced its Phase III switching study results for SB15 which confirmed interchangeability and biosimilarity with Eylea®.