Synonyms: AVE0005 | Eylea® | VEGF Trap | Zaltrap® | ziv-aflibercept
aflibercept is an approved drug (FDA (2011), EMA (2012))
Compound class:
Peptide
Comment: Alfibercept is a fusion protein combining the Fc portion of human IgG with the ligand binding domains of the VEGRF1 and VEGRF2 receptors.
Biosimilars: Patent protection for originator alfibercept was expected to expire earliest in Japan and China (2022), then in US (2023, if Regeneron's extended patent claims were accepted) and the EU (2025), and biosimilar development proceeded during the run-up to patent expiry [4]. Early examples included Momenta Pharmaceuticals/Mylan's M710MYL-1701P, Alteogen's ALT-L9 (a heat stabilised formulation with a predicted longer shelf-life than Eylea; NCT04058535), and Formycon/Santo Holdings' FYB203. The table below lists Eylea biosimilars with regulatory approval.
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References |
1. Chang AA, Li H, Broadhead GK, Hong T, Schlub TE, Wijeyakumar W, Zhu M. (2014)
Intravitreal aflibercept for treatment-resistant neovascular age-related macular degeneration. Ophthalmology, 121 (1): 188-92. [PMID:24144450] |
2. Chu QS. (2009)
Aflibercept (AVE0005): an alternative strategy for inhibiting tumour angiogenesis by vascular endothelial growth factors. Expert Opin Biol Ther, 9 (2): 263-71. [PMID:19236257] |
3. Seo N, Guan X, Wang T, Chung HSH, Wikström M, Padaki R, Kalenian K, Kuhns S, Matthies K, Crouse-Zeineddini J et al.. (2024)
Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product. Ophthalmol Ther, 13 (5): 1303-1320. [PMID:38507189] |
4. Sharma A, Reddy P, Kuppermann BD, Bandello F, Lowenstein A. (2018)
Biosimilars in ophthalmology: "Is there a big change on the horizon?". Clin Ophthalmol, 12: 2137-2143. [PMID:30498330] |
5. Tang PA, Moore MJ. (2013)
Aflibercept in the treatment of patients with metastatic colorectal cancer: latest findings and interpretations. Therap Adv Gastroenterol, 6 (6): 459-73. [PMID:24179482] |