On 24 November 2025, Formycon and Italian based pharmaceutical manufacturer NTC, jointly announced that Klinge Biopharma, the exclusive owner of the global commercialisation rights of Formycon’s aflibercept biosimilar, FYB203/Baiama®, finalised an exclusive commercialisation agreement with NTC in Italy.
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 (standard patent term expiry on 14 June 2027). The dispute between Regeneron/Bayer and Formycon in relation to FYB203 includes legal proceedings in Germany, the US, UK, Italy, Belgium, the Netherlands, and France.
FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive®, and UK approval in February 2025. In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 (as Ahzantive®) in Europe (excluding Italy) and Israel. On 17 September 2025, Formycon announced that Klinge had entered a semi-exclusive licence agreement with Horus Pharma, for the commercialisation of FYB203 (under the brand name Baiama®) in selected European countries.