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 additional semi-exclusive license agreement with Horus Pharma (“Horus”) for the commercialization of FYB203/Baiama®2 in selected European countries. The agreement follows the semi-exclusive partnership signed in January with Teva Pharmaceuticals International GmbH (“Teva”) for the commercialization of FYB203/AHZANTIVE®3 covering major parts of Europe and Israel.

Upon signature, 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.

Aflibercept is used to treat neovascular age-related macular degeneration (nAMD), the leading cause of blindness and visual disability in patients aged over 60 years in Europe and North America, as well as other severe retinal diseases.

Nicola Mikulcik, CBO of Formycon AG says: “We are very pleased that we could add Horus Pharma, a distinguished specialist in ophthalmology, to the group of our excellent commercial partners. Horus will market the brand Baiama® in selected European markets including its home market France. Baiama® will be sold as a second brand in addition to AHZANTIVE®, which will be launched by Teva across Europe. Teva is already successfully marketing our Lucentis®4 biosimilar Ranivisio®5. With our two-brand-partner strategy we are striving for the best possible therapeutic coverage to fully leverage the high market potential in Europe.”

Horus Pharma is the second largest independent ophthalmological laboratory in France and a leading player in Europe. For more than 20 years, the independent laboratory has been recognized for its know-how in developing preservative-free products in ophthalmology. Thanks to a sustained Research & Development policy, Horus Pharma is improving the daily lives of patients by developing and distributing solutions and products for all segments of eye health.

In June 2024, the aflibercept biosimilar FYB203 was approved by the US Food and Drug Administration (“FDA”). Approval by the European Commission under the brand names AHZANTIVE® and Baiama® followed in January 2025. One month later, FYB203 also received marketing authorization by the British MHRA.6

 


 

1)Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2)Baiama® is a registered trademark of Klinge Biopharma GmbH
3)AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
4)Lucentis® is a registered trademark of Genentech Inc.
5)Ranivisio® is a registered trademark of Bioeq AG
6)The commercial launch of FYB203 in Europe depends on the progress and outcome of ongoing
or potential future patent litigation or possible settlement agreements.

Alira Health has acted as strategic advisor to Klinge and Formycon
in the transaction with Horus Pharma.