Formycon Receives Approval in the UK for Eylea Biosimilar

Formycon and its licensing partner Klinge Biopharma jointly announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved FYB203 (aflibercept), a biosimilar to Eylea (Regeneron), under the brand name Ahzantine.

The approval covers the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME), visual impairment due to myopic choroidal neovascularisation (CNV), and macular edema following retinal vein occlusion (RVO).

“With the approval of FYB203, our second ophthalmic biosimilar in the UK, we take yet another significant step in making essential ophthalmic therapies more widely available,” Dr. Stefan Glombitza, CEO of Formycon AG, said in a company news release. “In addition to Ongavia, our successful ranibizumab biosimilar in the UK, Ahzantine will provide a new, cost-efficient treatment option for patients with severe retinal diseases, through our strong commercial partner Teva."

The FDA granted marketing authorization for FYB203 in June 2024, followed by European Commission`s approval in January 2025. Recently, Formycon and Teva Pharmaceuticals International 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. According to Formycon, Teva is already marketing Formycon’s FYB201 ranibizumab Biosimilar (Ongavia) in the UK and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field.