FDA Approves Afibercept-Boav as Biosimilar to Afibercept for Diabetic Macular Edema

The FDA approved aflibercept-boav (Eydenzelt) as a biosimilar referencing aflibercept (Eylea) for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy.¹

"Advanced age-related macular degeneration is a leading cause of irreversible blindness and visual impairment in the world, and nearly 20 million people in the US are living with some form of age-related macular degeneration," David M. Brown, MD, FACS, director of Retina Consultants of Texas Research Centers, said in a news release.¹ "Eydenzelt will be an important new addition to our options for the treatment of our patients with serious retinal diseases."

The approval was based on analytical, nonclinical, and clinical data, including a phase 3 study of the biosimilar for patients with DME. In the 52-week trial (NCT04739306), investigators included 348 patients with DME to determine the safety and biosimilarity between the biosimilar and reference product. The primary outcome included mean change from baseline in best corrected visual acuity (BCVA) at week 8, and secondary end points included mean change from baseline in BCVA at week 52, proportion of patients who gained 15 or more letters at 52 weeks, proportion of individuals with a 2-step or more improvement in Diabetic Retinopathy Severity Score at week 52, and change from baseline in central subfield thickness.^1,2

Overall, 153 patients in the biosimilar group and 153 in the reference product group completed the study through week 52. The improvements in BCVA score were maintained through week 52 at 12.1 letters compared with 11.1 letters, respectively. Furthermore, changes in baseline in CST and other efficacy end points were comparable between the 2 groups. Further, treatment-emergent adverse events (AEs) and immunogenicity were also comparable, according to the investigators.³

In the initial study that lasted 8 weeks, investigators noted that the BCVA improved by 9.43 and 8.85 letters for the biosimilar and reference groups, respectively. Through week 24, the other end points remained similar. The pharmacokinetics, usability, safety, and immunogenicity were comparable between the biosimilar and reference product groups.⁴

"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 US," Juby Jacob-Nara, MD, senior vice president and chief medical officer at Celltrion USA, said in the news release. "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."

READ MORE: Biosimilars Resource Center

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REFERENCES

1. Celltrion receives US FDA approval for Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept). News release. Celltrion. October 10, 2025. Accessed October 14, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/4201

2. Study to compare efficacy and safety of CT-P42 in comparison with Eylea in patiens with diabetic macular edema. ClinicalTrials.gov identification: NCT04739306. Updated December 5, 2023. Accessed October 14, 2025. https://clinicaltrials.gov/study/NCT04739306

3. Brown DM, Wolf S, Veselovsky M, et al. Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial. Ophthalmol Ther. Published online August 29, 2025. doi:10.1007/s40123-025-01197-w

4. Wolf S, Stanga PE, Veselovsky M, et al. Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase III Study. Ophthalmol Retina. 2024;8(12):1163-1173. doi:10.1016/j.oret.2024.06.013