On 19 March 2026, Formycon and Klinge announced they have entered into a settlement and licence agreement with Regeneron/Bayer for FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg, in Europe and key markets in the Latin American and Asia-Pacific regions. The agreement permits launch of FYB203 in Europe and the other licensed regions from May 2026. FYB203 is set to launch in the US in Q4/2026 following a separate settlement of BPCIA litigation in October 2025.
The recent settlement resolves all EU patent disputes related to FYB203, including in Germany where, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction against Formycon preventing the launch of FYB203 across 20 European countries until the expiry of Regeneron’s aflibercept formulation patent EP2364691. There have also been legal proceedings in relation to FYB203 in at least the UK, Italy, Belgium, the Netherlands, and France.
FYB203 received European marketing approval in January 2025 under the brand names Ahzantive® and Baiama®. It was developed by Formycon, and Klinge holds the exclusive 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).
In the Asia Pacific region, Formycon/Klinge have exclusively licensed FYB203 commercialisation rights to Lotus Pharma for various Asian countries (February 2025) and to Actor Pharmaceuticals for Australia (October 2025). A patent revocation action brought by Actor Pharmaceuticals in Australia relating to Regeneron’s method of treatment patent AU2012205599 relating to Eylea® (with a cross-claim for infringement by Regeneron/Bayer) was discontinued by consent on 18 March 2026, presumably in connection with the recent settlement.
In Latin America, Klinge has exclusively licensed the FYB203 commercialisation rights to Uruguay-based Megalabs (October 2025). According to Formycon, it has been working closely with Megalabs to prepare marketing applications for Latin American countries.
Biosimilars of Regeneron/Bayer’s Eylea® 2mg are already on the market around the world, including, for example, Alvotech’s Mynzepli® (launched in the UK, Canada and Japan), Amgen’s Pavblu® (available in the US), Sandoz’s Afqlir®/Enzeevu® (launched in the UK, Australia and Canada), Samsung Bioepis’ Afilivu®/Opuviz® (available in Korea) and Celltrion’s Eydenzelt® (launched in the UK and Europe).