The US Food and Drug Administration (FDA) was busy in June 2024. On 28 June 2024, the FDA granted approval for Formycon’s Ahzantive (aflibercept-mrbb), making it the third approval for a biosimilar referencing Eylea.
The announcement of Ahzantive/FYB203 by Formycon and its licensing partner Klinge Pharma follows the news of approvals of Biocon Biologic’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen's Opuviz (aflibercept-yszy) as the first interchangeable biosimilars to Regeneron and Bayer's Eylea [1].
The FDA has approved biosimilar Ahzantive (aflibercept-mrbb) in the formulations of 2 mg/0.05 mL of 40 mg/mL injection.
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor [2], a recombinant fusion protein consisting of portions of VEG-binding portions from the extracellular domains of human VEGF receptors 1 and 2, that are fused to the Fc portion of the human IgG1 immunoglobulin.
Ahzantive received FDA approval for treating patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases, including diabetic macular oedema, diabetic retinopathy, and macular oedema following retinal vein occlusion. 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.
A marketing authorization application for FYB203 was also submitted to the European Medicines Authority (EMA) at the end of 2023, with a decision anticipated by early 2025.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable aflibercept biosimilars to treat macular degeneration [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 13]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-aflibercept-biosimilars-to-treat-macular-degeneration
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 13]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept/
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