Yesafili FDA Approval History
Last updated by Judith Stewart, BPharm on May 21, 2024.
FDA Approved: Yes (First approved May 20, 2024)
Brand name: Yesafili
Generic name: aflibercept-jbvf
Dosage form: Injection
Company: Biocon Biologics Inc.
Treatment for: Macular Degeneration, Macular Edema Following Retinal Vein Occlusion , Diabetic Macular Edema, Diabetic Retinopathy
Yesafili (aflibercept-jbvf) is a vascular endothelial growth factor (VEGF) inhibitor interchangeable biosimilar to Eylea indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
- Unlike Eylea (aflibercept), Yesafili is not indicated for the treatment of patients with retinopathy of prematurity.
- Yesafili is biosimilar to Eylea and has an interchangeability designation.
- Yesafili is administered by intravitreal injection.
- FDA approval of Yesafili was based on a comprehensive review of scientific evidence that demonstrated the product is highly similar to Eylea, and that there were no clinically meaningful differences from Eylea.
- Warnings and precautions associated with Yesafili include endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion; increases in intraocular pressure; and risk of arterial thromboembolic events.
- Common adverse reactions include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
- Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) are the first FDA-approved Eylea biosimilars, both approved on May 20, 2024.
Development timeline for Yesafili
| Date | Article |
|---|---|
| May 20, 2024 | Approval FDA Approves Yesafili (aflibercept-jbvf), an Interchangeable Biosimilar to Eylea |
Further information
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