FDA Approves Eydenzelt Biosimilar of Eylea
- The FDA has approved Eydenzelt (aflibercept-boav), a biosimilar referencing Eylea (aflibercept, Regeneron), for the treatment of four retinal diseases: wet age-related macular degeneration, macular edema following retinal vein...
- The approval was based on analytical,nonclinical,and clinical data,including a phase 3 trial demonstrating therapeutic equivalence to Eylea in patients wiht diabetic macular edema (DME).
- Eydenzelt previously received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in December 2024 and European commission approval in February.
FDA Approves Eydenzelt, a Biosimilar to Eylea, for Retinal Diseases
The FDA has approved Eydenzelt (aflibercept-boav), a biosimilar referencing Eylea (aflibercept, Regeneron), for the treatment of four retinal diseases: wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
The approval was based on analytical,nonclinical,and clinical data,including a phase 3 trial demonstrating therapeutic equivalence to Eylea in patients wiht diabetic macular edema (DME). The trial showed similar efficacy, safety, and immunogenicity trends between the two drugs.
Eydenzelt previously received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in December 2024 and European commission approval in February.
Wellband Jacob-Nara, MD, DHSc, MPH, MBA, senior vice president and chief medical officer at Celltrion USA, stated that the approval represents a meaningful milestone in the treatment of retinal diseases, offering physicians more options and possibly improving patient outcomes.
Source: https://www.healio.com/news/ophthalmology/20240503/fda-approves-eydenzelt-biosimilar-to-eylea