FDA Approves Celltrion Aflibercept Biosimilar: Eydenzelt

FDA approves Celltrion's Eydenzelt, a new aflibercept biosimilar, enhancing treatment options for retinal diseases in the US. | Image credit: Tada Images - stock.adobe.com

The FDA has approved Eydenzelt (aflibercept-boav), an aflibercept biosimilar developed by Celltrion to reference Eylea (aflibercept), an anti-vascular endothelial growth factor used to treat retinal diseases.¹

The American approval comes after the same biosimilar received marketing authorization from the European Commission in February 2025.²

"Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have Eydenzelt approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the U.S.," said Juby Jacob-Nara, PhD, senior vice president and chief medical officer at Celltrion USA.¹ "With Eydenzelt demonstrating biosimilarity to its reference product, we believe this approval will mark a significant milestone in the treatment landscape of retinal diseases—helping physicians broaden their options and improving patient outcomes."

Aflibercept products are administered intravitreally in a physician's office and is designed to blcok the growth of new blood vessels and decrease vascular permeability in the eye, 2 factors involved in ocular angiogenesis.

Eydenzelt is approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy.

The FDA based its approval on a totality of evidence, including analytical, nonclinical, and clinical data.

In a randomized, double-masked, parallel-group, multicenter phase III study, the efficacy, safety, pharmacokinetics, and immunogenicity of Eydenzelt were compared with Eylea in patients with DME.

The primary endpoint was the change in best corrected visual acuity from baseline to week 8, comparing Eydenzelt with Eylea. The 52-week trial enrolled 348 patients with DME. Results showed that Eydenzelt met the predefined equivalence criteria, and secondary endpoints related to efficacy, safety, and immunogenicity demonstrated trends consistent with those observed for Eylea.

Eydenzelt represents Celltrion’s first FDA-approved biologic product in ophthalmology. It is also the sixth aflibercept approval in the US, following the FDA's authorizations of Pavblu (aflibercept-ayyh), Enzeevu (aflibercept-abzv), Ahzantive (aflibercept-mrbb), Yesafili (aflibercept-jbvf), and Opuviz (aflibercept-yszy).^3-6

References

1. Celltrion receives U.S. FDA approval for Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept). News release. Celltrion. October 9, 2025. Accessed October 13, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/4201
2. Jeremias S. EC approves Celltrion denosumab, aflibercept biosimilars. The Center for Biosimilars^®. February 20, 2025. Accessed October 13, 2025. https://www.centerforbiosimilars.com/view/ec-approves-celltrion-denosumab-aflibercept-biosimilars
3. Jeremias S. FDA approves Pavblu for retinal conditions. The Center for Biosimilars. September 17, 2024. Accessed October 13, 2025. https://www.centerforbiosimilars.com/view/fda-approves-pavblu-for-retinal-conditions
4. Jeremias S. FDA approves biosimilar Enzeevu for eye conditions. The Center for Biosimilars. August 12, 2024. Accessed October 13, 2025. https://www.centerforbiosimilars.com/view/fda-approves-biosimilar-enzeevu-for-eye-conditions
5. Jeremias S. FDA approves first Eylea biosimilars. The Center for Biosimilars. May 20, 2024. Accessed October 13, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-eylea-biosimilars
6. Jeremias S. Ahzantive receives FDA approval as new Eylea biosimilar. The Center for Biosimilars. July 1, 2024. Accessed October 13, 2025. https://www.centerforbiosimilars.com/view/ahzantive-receives-fda-approval-as-new-eylea-biosimilar