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Samsung Bioepis Presents Switching Study Results for SB15, Biosimilar to Regeneron’s Eylea® (aflibercept)

Oct 7, 2023

Samsung Bioepis announced its Phase III switching study results for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), at EURETINA 2023.  The results comparable clinical efficacy when switching to SB15 from Eylea® for patients with neovascular age-related macular degeneration (nAMD), confirming interchangeability and biosimilarity.

On 8 June 2023, JAMA Ophthalmology published the Ph III trial results for SB15, and demonstrating equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to Eylea® in participants with nAMD.  In April 2023, Samsung Bioepis announced 1-year outcomes of its Ph III study at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.