The United States Food and Drug Administration (FDA) has approved FYB203/Ahzantive (aflibercept-mrbb), a biosimilar to Eylea developed by Formycon.
Formycon also has a Lucentis biosimilar FYB201 which was previously given the FDA’s greenlight.
FYB203/Ahzantive obtained FDA approval for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases such as diabetic macular oedema, diabetic retinopathy, and macular oedema following retinal vein occlusion.
The active ingredient inhibits vascular endothelial growth factor (VEGF), which is responsible for excessive formation of blood vessels in the retina.
In 2023, Eylea reached global sales of around US$ 9 billion,1 confirming its status as the currently best-selling drug in the field of anti-VEGF therapies.
In a media release2 Formycon stated that the “FDA approval for FYB203/Ahzantive is based on a thorough evaluation of our comprehensive data package including analytical, pre-clinical, clinical and manufacturing data.
FYB203/Ahzantive demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Eylea in patients with nAMD.”
A marketing authorisation application for FYB203 was submitted to the European Medicines Agency at the end of 2023 with a decision expected by early 2025 at the latest.
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Reference
1. Regeneron reports fourth quarter and full year 2023 financial and operating results. Media release 2 February 2024. Available at: investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial.
2. Formycon receives FDA approval for fyb203/ahzantive (aflibercept-mrbb), a biosimilar to Eylea. Media release 1 July 2024. Available at: formycon.com/en/blog/press-release/formycon-receives-fda-approval-for-fyb203-ahzantive.
