FDA Approves Eydenzelt Biosimilar of Eylea

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