Shots:
The Korean MFDS has approved Eyzanfy (ALT-L9), a biosimilar version of Eylea (aflibercept)
In 2025, ALT-L9 received EC approval as a brand name of Eyluxvi
Approval was based on P-III trial across 12 countries in 431 wAMD pts, demonstrating Eyluxvi’s efficacy, safety, and therapeutic equivalence comparable to Eylea
Ref: Alteogen | Image: Alteogen | Press Release
Related News:- Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s…
Shots:
The EC has approved Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation
Approval was based on P-III trials conducted across the EU, South Korea, & Japan,…
Shots:
The CHMP has recommended Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation
Opinion was based on extensive analytical, non-clinical, & clinical data incl. a P-III trial…

