Biocon Biologics Reports the Health Canada’s NOC for Yesafili (Biosimilar, Eylea)
Shots:
- Health Canada has granted NOC for Yesafili (vial & PFS presentations, 2 mg/0.05 mL), a biosimilar to Eylea (aflibercept), anticipated launch on Jul 04, 2025
- Approval was supported by the P-III (INSIGHT) study in Diabetic Macular Edema(DME), which showed no clinically meaningful differences from EYLEA in PK, safety, efficacy, or immunogenicity.
- YESAFILI is a VEGF inhibitor approved for the treatment of Neovascular (wet) age-related macular degeneration (AMD), Visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO), Visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO), DME, and Myopic choroidal neovascularization (myopic CNV)
Ref: Globenewswire | Image: Biocon Biologics| Press Release
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