On 16 October 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), has entered exclusive licence agreements with Actor Pharmaceuticals and Uruguay-based Megalabs S.A. for the commercialisation of FYB203 in Australia and Latin America, respectively.
Under the agreements, Klinge is eligible to receive upfront and milestone payments and royalties on net sales. Formycon will participate in all payment streams to Klinge, in the mid-single digit to low-double digit percentage range and will receive additional payments for organising the commercial market supply on behalf of Klinge.
According to Formycon, a regulatory application for FYB203 has been submitted to the Australian Therapeutic Goods Administration (TGA), while Formycon is working closely with Megalabs to prepare marketing applications for Latin American countries.
The agreements follow semi-exclusive commercialisation agreements between Klinge and Horus Pharma (September 2025) and Klinge and Teva Pharmaceuticals (January 2025) for FYB203, covering major parts of Europe (excluding Italy) and Israel. Horus will market the product as Baiama®, while Teva will market it as Ahzantive®. In June 2025, Klinge entered an exclusive licence agreement with Valorum for commercialisation of FYB203 in the US and Canada.
FYB203/Ahzantive® was approved by the FDA in June 2024 and is set to launch in the US in Q4/2026 following settlement of BPCIA litigation between Formycon and Regeneron in October 2025. The biosimilar may launch in the UK in November 2025, following a February 2025 approval by the MHRA and a failed UK preliminary injunction bid by Regeneron in October 2025 (which is subject to any appeal). The situation is less clear in Europe, where, on 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203 in a number of European countries, including Germany. FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive®.