On 19 May 2026, Formycon and Klinge Biopharma announced that the European launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), commenced on 15 May 2026 in key European markets, including Germany, France and Italy.
The launch follows a March 2026 settlement agreement between Fomycon/Klinge and Regeneron/Bayer permitting commercialisation of FYB203 in Europe and other licensed regions (including key markets in LATAM and APAC) from May 2026. FYB203 is set to launch in the US in Q4/2026 following a separate settlement of BPCIA litigation in October 2025.
Formycon/Klinge received European approval for FYB203 in January 2025 under the brand names Ahzantive® and Baiama®. Formycon developed FYB203 and Klinge holds the exclusive global commercialisation rights. Klinge has entered into agreements with Teva Pharmaceuticals for the semi-exclusive commercialisation rights to FYB203 (as Ahzantive®) in Europe (excluding Italy) and Israel (January 2025), Horus Pharma for the semi-exclusive commercialisation rights to FYB203 (as Baiama®) in selected European countries (September 2025) and NTC for the exclusive commercialisation rights to FYB203 in Italy (November 2025).
Aflibercept biosimilars have 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 also permit further 2026 biosimilar aflibercept launches, including for Samsung Bioepis, Alvotech and Biocon.