On 15 June2024, Ophthalmology and Therapy published the results of a Samsung Bioepis-sponsored study which assessed the analytical similarity between Samsung Bioepis’ aflibercept biosimilar, SB15, and Regeneron’s Eylea® (aflibercept) sourced from the US and EU. The results showed that SB15 was analytically “highly similar” to US/EU sourced Eylea®, with comparable primary and higher-order structure, no meaningful differences in physiochemical properties in terms of size and charge heterogeneity, and similarity in biological activities.
Samsung Bioepis’ SB15 was approved in the US in May 2024 (as Opuviz® (aflibercept-yszy)) and in Korea in February 2024 as Aflilvu®.