UK MHRA Approves Aflibercept Biosimilar FYB203 (AHZANTIVE) from Formycon

Formycon AG has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for FYB203, a biosimilar to aflibercept (Eylea). The biosimilar will be marketed in the UK under the brand name AHZANTIVE.

FYB203 has been approved for the treatment of:

       • Neovascular age-related macular degeneration (nAMD)

       • Diabetic macular edema (DME)

       • Macular edema following retinal vein occlusion (RVO)

       • Visual impairment due to myopic choroidal neovascularization (mCNV)

Regulatory Progress in the EU and US

Formycon’s biosimilar has also achieved key regulatory milestones beyond the UK:

       • November 2024 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Formycon’s marketing authorization application.

       • January 2025 – The European Commission approved FYB203 under the brand names AHZANTIVE and Baiama for use in the EU.

       • June 2024 – The U.S. Food and Drug Administration (FDA) approved FYB203 (aflibercept-mrbb), based on comprehensive analytical, preclinical, clinical, and manufacturing data demonstrating comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference product.

Commercialization Partnership with Teva Pharmaceuticals

Formycon, headquartered in Munich, Germany, has partnered with Teva Pharmaceuticals for the commercialization of FYB203. Teva is also the European commercialization partner for FYB201, Formycon’s biosimilar to ranibizumab (Lucentis), marketed as Ranivisio and Ongavia across Europe.

Stefan Glombitza, CEO of Formycon AG, emphasized the importance of this approval:

“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. In addition to Ongavia, our successful ranibizumab biosimilar in the UK, AHZANTIVE will provide a new, cost-efficient treatment option for patients with severe retinal diseases, through our strong commercial partner Teva.”

Expanding Access to Cost-Effective Retinal Disease Treatments

The approval of FYB203 (AHZANTIVE) represents a significant advancement in the availability of cost-efficient biosimilar treatments for serious retinal conditions, providing clinicians and patients with more accessible therapeutic options for vision-threatening diseases.