FDA approves Eydenzelt as biosimilar referencing Eylea
October 10, 2025
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Key takeaways:
- Eydenzelt is accepted for 4 retinal illnesses, together with moist age-related macular degeneration and diabetic macular edema.
- This biosimilar obtained European Fee approval in February.
Editor’s observe: This can be a creating information story. Please verify again quickly for updates.
The FDA accepted Eydenzelt, a biosimilar referencing Eylea, for the therapy of 4 retinal illnesses, in response to a press launch from Celltrion.
The FDA accepted Eydenzelt, a biosimilar referencing Eylea, for the therapy of 4 retinal illnesses.
These circumstances embrace moist age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.
Based on the discharge, the FDA based mostly its determination on Eydenzelt (aflibercept-boav) on analytical, nonclinical and scientific information. Notably, a randomized, double-masked, parallel-group, multicenter, 52-week section 3 trial discovered that Eydenzelt demonstrated therapeutic equivalence to Eylea (aflibercept, Regeneron) by predefined standards in sufferers with DME, in addition to comparable efficacy, security and immunogenicity traits.
Healio beforehand reported that the Committee for Medicinal Merchandise for Human Use of the European Medicines Company granted a constructive opinion for Eydenzelt in December 2024, and it obtained European Fee approval in February.
“With Eydenzelt demonstrating biosimilarity to its reference product, we imagine this approval will mark a big milestone within the therapy panorama of retinal illnesses — serving to physicians broaden their choices and enhancing affected person outcomes,” Juby Jacob-Nara, MD, DHSc, MPH, MBA, senior vice chairman and chief medical officer at Celltrion USA, stated within the launch.
