Enzeevu FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 13, 2024.
FDA Approved: Yes (First approved August 9, 2024)
Brand name: Enzeevu
Generic name: aflibercept-abzv
Dosage form: Injection
Company: Sandoz Inc.
Treatment for: Macular Degeneration
Enzeevu (aflibercept-abzv) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Eylea indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD).
- Unlike Eylea (aflibercept), Enzeevu is not indicated for the treatment of patients with macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, or retinopathy of prematurity.
- Enzeevu is biosimilar to Eylea and does not have an interchangeability designation.
- Enzeevu is administered by intravitreal injection.
- FDA approval of Enzeevu 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 Enzeevu include endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion; increases in intraocular pressure; and potential risk of arterial thromboembolic events.
- Common adverse reactions include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
- Enzeevu is the fourth FDA-approved Eylea biosimilar, following the approvals of Ahzantive (aflibercept-mrbb), Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) in 2024.
Development timeline for Enzeevu
| Date | Article |
|---|---|
| Aug 12, 2024 | Approval FDA Approves Enzeevu (aflibercept-abzv), a Biosimilar to Eylea |
| Aug 16, 2023 | Sandoz Announces Positive Results from Mylight Phase lll Study for Biosimilar Aflibercept |
Further information
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