On 31 May 2026, Samsung Bioepis announced that it has launched Opuviz™/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg, in Europe through direct sales.
The launch follows a settlement agreement between Samsung Bioepis and Regeneron/Bayer in relation to the aflibercept biosimilar announced in January 2026. Under the agreement, Samsung Bioepis was permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement from May 2026 (excluding Korea where it had already been on the market as Afilivu® since 2024). Samsung Bioepis has a separate settlement agreement with Regeneron/Bayer for North America, permitting launch of Opuviz™ in the US from January 2027.
Opuviz™ was the third aflibercept biosimilar to be approved in the EU in November 2024 and has been approved elsewhere, including the UK (April 2025), the US (May 2024), Korea (as Afilivu®) (February 2024) and Australia (September 2025).
The European launch of Opuviz™ comes two weeks after Formycon/Klinge launched their aflibercept biosimilar, FYB203, in key European markets. Aflibercept biosimilars have also been launched in Europe including by Sandoz (Afqlir® launched in UK in November 2025) and Celltrion (Eydenzelt® launched in UK and EU in December 2025). Settlement agreements between Regeneron/Bayer and other companies permit further 2026 EU biosimilar aflibercept launches, including for Alvotech and Biocon.