Ahzantive Receives FDA Approval as New Eylea Biosimilar

Formycon and its licensing partner Klinge Biopharma announced the FDA approval for Ahzantive (aflibercept-mrbb), making it the third approval for a biosimilar referencing Eylea (aflibercept).¹

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The approval follows those for Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis' Opuviz (aflibercept-yszy), which were approved in May 2024. Aflibercept products are administered intravitreally and inhibit vascular endothelial growth factor, which causes excessive blood vessel formation in the retina.

Ahzantive has received FDA approval for treating patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases, including diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion.

“The FDA approval of FYB203/Ahzantive is another key milestone on our way to becoming the leading pure-play biosimilar developer. It highlights the expertise and experience of our team. With the Eylea® biosimilar FYB203/Ahzantive and our already approved Lucentis biosimilar FYB201, we have achieved an outstanding position in ophthalmic biosimilar therapies. We are thus improving healthcare for patients with retinal diseases by offering effective, safe and, above all, affordable treatment options,” commented Stefan Glombitza, PhD, CEO of Formycon.

Additionally, a marketing authorization application for Ahzantive was submitted to the European Medicines Agency (EMA) at the end of 2023. A decision from the EMA is anticipated by early 2025.

The FDA’s decision was based on a comprehensive data package including research comparing the safety, efficacy, and tolerability of Ahzantive (FYB203) with that of Eylea in patients with nAMD. Formycon published that the MAGELLAN-AMD phase 3 randomized, double-blind, multicenter analysis (NCT04522167) met its primary end points demonstrating comparable efficacy between FYB203 and Eylea.

In the study, participants with nAMD aged 50 and older were randomized 1:1 to receive the biosimilar or reference product every 4 weeks for the first 3 consecutive doses, followed by 1 intravitreal injection every 8 weeks through study completion. Results showed that the 2 products had comparable biosimilarity and no new safety signals were identified.

AMD is the leading cause of visual impairment and blindness in Europe, and its prevalence is expected to rise, necessitating updated data for health care planning. A systematic review and meta-analysis of studies since 1996 estimated that 25.3% of individuals 60 years and older have early or intermediate AMD, and 2.4% have late AMD.²

The annual incidence of late AMD is 1.4 per 1000 individuals. By 2050, the number of people with AMD in the European Union is expected to increase from 67 million to 77 million, with late AMD cases rising from 400,000 to 700,000 per year. This growing burden highlights the need for additional health care resources and planning.

References

1. Formycon receives FDA approval for FYB203/Ahzantive®) (aflibercept-mrbb), a biosimilar to Eylea®). News release. Formycon. July 1, 2024. Accessed July 1, 2024. https://www.formycon.com/en/blog/press-release/formycon-receives-fda-approval-for-fyb203-ahzantive/

2. Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis. Br J Ophthalmol. 2020;104:1077-1084. doi:10.1136/bjophthalmol-2019-314422