On 10 August 2026, Samsung Bioepis announced the European launch of Opuviz®/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2mg in a pre-filled syringe (PFS) presentation (40 mg/mL). Opuviz® was the third aflibercept biosimilar to be approved in the EU in November 2024 and was launched in Europe in a vial form in May 2026.
The original launch of Opuviz® followed a settlement agreement between Samsung Bioepis and Regeneron/Bayer announced in January 2026 under which 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 SB15 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).
Other aflibercept biosimilars launched in UK/Europe, including in PFS form, include Sandoz’s Afqlir® (UK launch in November 2025), Celltrion’s Eydenzelt® (UK/EU launch in December 2025), Biocon’s Yesafili® (UK launch in January 2026), Alvotech’s Mynzepli® (UK launch January 2026) and Formycon/Klinge’s Ahzantive®/Baiama® (EU launch in May 2026).