Formycon AG and its licensing partner Klinge Biopharma GmbH have been granted marketing authorisation by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for FYB203 (aflibercept), a biosimilar to Eylea®1, under the brand name AHZANTIVE®2.
The approval covers the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal conditions, including Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO). Aflibercept is an inhibitor of the vascular endothelial growth factor (VEGF), which plays a key role in the abnormal formation of blood vessels in the retina, leading to vision impairment.
The UK market authorization follows successful regulatory approvals by the U.S. Food and Drug Administration (FDA) and the European Comission for FYB203. The U.S. Food and Drug Administration (FDA) had already granted marketing authorization for FYB203 in June 2024, followed by European Commission’s approval in January 2025.
Teva Pharmaceuticals will market FYB203 / AHZANTIVE®2 in major parts of Europe, including the United Kingdom. Recently, Formycon and Teva Pharmaceuticals International GmbH (Teva) announced a partnership for the semi-exclusive commercialization of FYB203 across major parts of Europe, including the United Kingdom, and Israel. Concurrently, Formycon had concluded an agreement with Teva for product supply. Teva is already marketing Formycon’s FYB201 ranibizumab Biosimilar (Ongavia®3) in the UK and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field.
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1) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
3) Ongavia® is a registered trademark of Teva Pharmaceuticals Limited