Formycon Expands Global Access to FYB203 Through Licensing Agreements in Australia and Latin America

Formycon AG, a Germany-based biopharmaceutical company, has announced that its licensing partner, Klinge Biopharma, the exclusive global commercialization rights holder for FYB203 (aflibercept), a biosimilar to Eylea®, has signed two new exclusive agreements to extend the product’s international presence. The new licensing deals cover key markets in Australia and Latin America, supporting Formycon’s strategy to make FYB203 more widely available to patients worldwide.

New Licensing Partnerships in Australia and Latin America

Klinge Biopharma has finalized:

       • An exclusive licensing agreement with Actor Pharmaceuticals for the commercialization of FYB203 in Australia

       • A separate exclusive licensing agreement with Megalabs SA, covering Latin American countries

Under both agreements, Klinge will receive upfront and milestone payments, as well as royalties based on net sales. Formycon will participate in these revenues at a mid-single-digit to low-double-digit percentage. In addition, Formycon will act as the authorized designee for the commercial supply chain, earning service fees and volume-based profit for managing market supply.

“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 at 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.”

Regulatory Status of FYB203

FYB203 has already achieved several significant regulatory approvals in major markets:

       • U.S. FDA approval – June 2024

       • European Commission approval – January 2025

       • UK MHRA approval – February 2025

For Australia, a regulatory application is currently under review by the Therapeutic Goods Administration (TGA). In Latin America, Formycon is actively working with Megalabs to prepare submissions for the respective national health authorities.

Commercial launch timelines in both regions will depend on final regulatory approvals as well as the outcome of ongoing or potential patent litigation or settlement discussions in each jurisdiction.

Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc.