Shots:
- The CHMP has recommended FYB203 under the brand names, Ahzantive/Baiama, biosimilar version of Eylea (aflibercept), with the decision anticipated in 2nd half of Jan’25
- The approval, if granted, will be valid across the whole EU, as well as in Iceland, Liechtenstein & Norway. It is already approved across the US in Jun 2024
- FYB203 (VEGF inhibitor) is indicated for adults with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other retinal disorders such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularization (CNV) and Macular Edema following Retinal Vein Occlusion (RVO)
Ref: Fresenius Kabi and Formycon| Image: Fresenius Kabi and Formycon| Press Release
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