Shots:
- Health Canada has approved Eydenzelt, a biosimilar version of Eylea (aflibercept 2mg), in both vial & PFS presentation for all the indications of the reference product
- Approval was based on extensive analytical, nonclinical, & clinical data, incl. a global 52wk. P-III trial of Eydenzelt vs Eylea in 348 pts with diabetic macular edema, which met its 1EP of change in best corrected visual acuity at Wk. 8, along with 2EPs of comparable efficacy, safety, & immunogenicity
- Additionally, Eydenzelt, a fusion protein that inhibits VEGF-A & PlGF to reduce neovascularization & vascular leakage in retinal diseases, received EC approval in Feb 2025 & FDA approval in Oct 2025
Ref: PRNewswire | Image: Celltrion | Press Release
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