UK MHRA issues approval for aflibercept biosimilar FYB203 (AHZANTIVE) from Formycon

Formycon AG announced in a press release that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for FYB203, a biosimilar to aflibercept (Eylea). FYB203 received MHRA approval for the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular edema, macular edema following retinal vein occlusion, and visual impairment due to myopic choroidal neovascularization.¹

The biosimilar will be marketed in the UK under the brand name AHZANTIVE. In November of 2024, the European Union’s Committee for Medicinal Products for Human Use issued a positive recommendation for Formycon’s marketing authorization application.² In January 2025, the European Commission granted approval of the marketing authorization under the names AHZANTIVE and Baiama in the EU.

Formycon, based in Munich, Germany, will partner with Teva Pharmaceuticals to commercialize FYB203, as announced earlier this year.³ Teva is already the European commercialization partner for FYB201, Formycon's biosimilar to ranibizumab (Lucentis), marketed as Ranivisio and Ongavia throughout Europe.

“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,” said Stefan Glombitza, CEO of Formycon AG.¹ “In addition to Ongavia®3, 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.”

In June 2024, the US Food and Drug Administration (FDA) approved the biosimilar FYB203, also known as aflibercept-mrbb. In a press release at that time, the company stated that FDA approval was rooted in the company's “comprehensive data package” that included “analytical, pre-clinical, clinical, and manufacturing data.” Study results showed that FYB203 demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference product in patients with nAMD.²

References

1. Formycon receives regulatory approval in the UK for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand name AHZANTIVE. Press release. Formycon AG. Published February 25, 2025. Accessed February 25, 2025. https://www.formycon.com/en/blog/press-release/formycon-receives-regulatory-approval-in-the-uk-for-fyb203-aflibercept-a-biosimilar-to-eylea-under-the-brand-name-ahzantive/#:~:text=Planegg%2DMartinsried%2C%20Germany%20%E2%80%93%20Formycon,brand%20name%20AHZANTIVE%C2%AE2.

2. Crago S. CHMP issues positive opinion for marketing authorisation of aflibercept biosimilar FYB203 (Formycon). Ophthalmology Times Europe. Published November 19, 2024. Accessed February 25, 2025. https://europe.ophthalmologytimes.com/view/chmp-issues-positive-opinion-for-marketing-authorisation-of-aflibercept-biosimilar-fyb203-formycon-

3. Hayes H. Teva partners with Klinge Biopharma, Lotus Pharmaceutical for commercialisation of Formycon’s FYB203 (biosimilar aflibercept). Ophthalmology Times Europe. Updated February 5, 2025. Accessed February 25, 2025. https://europe.ophthalmologytimes.com/view/teva-partners-with-klinge-biopharma-for-commercialisation-of-formycon-s-fyb203-biosimilar-aflibercept-