Formycon Expands Global Reach of Eylea Biosimilar FYB203 with Licensing Deals in Australia and Latin America
Formycon AG announced that its licensing partner Klinge Biopharma, the exclusive global commercialization rights holder for Formycon’s Eylea¹ biosimilar FYB203 (aflibercept), has signed two new exclusive agreements to broaden the product’s international footprint.
Klinge has entered into an exclusive license agreement with Actor Pharmaceuticals for the commercialization of FYB203 in Australia, and a separate exclusive license agreement with Megalabs SA covering Latin America.
Under the terms of the agreements, Klinge will receive upfront and milestone payments, as well as royalties on net sales. Formycon will participate in these payment streams at a mid-single-digit to low-double-digit percentage and will also serve as authorized designee for the commercial supply chain. In this role, Formycon will earn additional service fees and a volume-based profit component for coordinating FYB203’s 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,” said Nicola Mikulcik, Chief Business Officer of Formycon AG. “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.
FYB203, Formycon’s biosimilar to Eylea (aflibercept), has achieved a series of major regulatory milestones:
US FDA approval in June 2024
European Commission approval in January 2025
UK MHRA approval in February 2025
For Australia, a regulatory application is currently under review by the Therapeutic Goods Administration (TGA). In Latin America, Formycon is working closely with Megalabs to prepare submissions to the respective national regulatory agencies. Commercial launches in Australia and Latin America will depend on regulatory approvals and the resolution of ongoing or potential patent litigation or settlement discussions in the respective regions.
¹ Eylea is a registered trademark of Regeneron Pharmaceuticals, Inc.