Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announces that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea®1 biosimilar FYB203 (aflibercept), concluded an exclusive license agreement with Actor Pharmaceuticals Pty. Ltd. (“Actor”) for the commercialization of FYB203 in Australia. Furthermore, for Latin America, Klinge has signed an exclusive license agreement with Megalabs S.A. (“Megalabs”).

Upon signature of the agreements, Klinge is eligible to receive upfront and milestone payments, plus royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from these agreements. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203 and will receive additional service payments and a volume-based profit component for organizing the commercial market supply on behalf of Klinge.

“Severe retinopathies are on the rise worldwide due to demographic trends and the increasing number of diabetes cases, which can lead to retinal diseases. With the partnerships for Australia and Latin America, Klinge has laid the foundation for making our Eylea® biosimilar FYB203 available as an effective and cost-efficient treatment option in further important regions of the world. With Actor and Megalabs, we have gained two strong distribution partners with excellent regional networks and a profound local market knowledge. Together, we are focused on improving the treatment options for the many patients who have been underserved in the past. At the same time, we are contributing to reduce the financial burden on healthcare systems,” says Nicola Mikulcik, Chief Business Officer (CBO) of Formycon AG.

Actor Pharmaceuticals is an established Australian pharmaceutical company specializing in the registration and commercialisation of innovative medicines and biosimilars in Australia. With a strong commitment to quality, patient access, and long-term partnerships, Actor Pharmaceuticals collaborates with global industry leaders to bring clinically proven therapies to the Australian market. The company’s expertise spans product registration, market access, and commercialization – driving growth across both prescription and over-the-counter segments.

Megalabs is a leading pharmaceutical company based in Uruguay with a strong presence and market position in the Americas. Megalabs is at the cutting edge of biotechnological innovation, with its High-Tech business unit serving as one of the main pillars of the organization’s success. The company’s various business areas also include the development, manufacturing and marketing of biosimilar products.

In June 2024, the aflibercept biosimilar FYB203 was approved by the US Food and Drug Administration (“FDA”). Approval by the European Commission followed in January 2025 and approval by the British MHRA one month later. For Australia, the regulatory application has been submitted to the Therapeutic Goods Administration (“TGA”). Formycon is also working closely with Megalabs to prepare the applications for approval in Latin American countries.2

Eylea® (aflibercept) is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The active ingredient inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

1) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.

2) The commercial launch of FYB203 in Australia and Latin America depends on several factors – firstly on approval by the respective regional regulatory authorities, and secondly on the progress and outcome of ongoing or potential future patent litigation or possible settlement agreements.