Samsung Bioepis announced the initiation of phase 3 clinical trial for SB15, the company’s proposed biosimilar referencing Eylea (aflibercept). The trial is a randomized, double-masked, parallel group, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB15 and Eylea in 446 patients with wet age-related macular degeneration.
Samsung Bioepis has two ophthalmology biosimilar candidates in clinical development, SB11 (ranibizumab) and SB15 (aflibercept). The company has recently announced 24-week interim results from a phase 3 clinical trial for SB11.
For more information, visit clinicaltrials.gov (NCT #04450329).