Aflibercept Biosimilar SB15 Shows Real-World Efficacy Across Retinal Diseases

Aflibercept 2 mg biosimilar SB15 (Afilivu; Samsung Bioepis) produced significant anatomical improvements and stable visual acuity across multiple retinal diseases, supporting its effectiveness and safety in both treatment-naïve and biosimilar-switching patient populations.¹

This large, multicenter, retrospective real-world study conducted in South Korea is published in Scientific Reports.

Aflibercept biosimilar SB15 improved retinal anatomy while preserving vision in both treatment-naive and switching patients with nAMD, RVO, and DME. | Image Credit: Orawan - stock.adobe.com

Evaluating Biosimilars Across a Broad Real-World Retinal Population

Biosimilars have become an increasingly important lever for expanding access to anti–vascular endothelial growth factor (VEGF) therapy amid the substantial treatment burden of chronic intravitreal injections. The AURA Korea study, conducted across 3 South Korean tertiary centers, evaluated outcomes among 1083 eyes from 984 patients who received a total of 2762 injections of SB15 between March 2023 and February 2025. The cohort included 188 treatment-naïve eyes (17.4%) and 895 eyes switched from another anti-VEGF agent (82.6%), spanning neovascular age-related macular degeneration (nAMD, n = 611), retinal vein occlusion (RVO, n = 182), diabetic macular edema (DME, n = 173), and other retinal conditions (n = 117).

Anatomical Gains Held Across Diagnoses, With Vision Preserved

Over a mean (SD) follow-up of 5.17 (2.76) months and 2.55 (1.09) injections per eye, central foveal thickness decreased significantly by −47.5 µm (95% CI, −55.2 to −39.8; P < .001), while best-corrected visual acuity (BCVA) remained stable (mean change, −0.003 _LogMAR; P = .572). Treatment-naïve eyes showed greater anatomical improvement than switching eyes (−93.9 µm vs −37.9 µm; P < .001).

Retinal fluid resolution was significant across all 3 major diagnostic groups: subretinal fluid in nAMD decreased from 51.2% to 29.6% (P < .001), intraretinal fluid in RVO fell from 92.9% to 76.4% (P < .001), and intraretinal fluid in DME declined from 90.8% to 84.4% (P = .002). Safety findings were reassuring, with only 1 case (0.09%) of rhegmatogenous retinal detachment and no episodes of intraocular inflammation or other serious adverse events reported.

These findings are broadly consistent with other real-world switching data in retinal disease. A United Kingdoom study of patients switched to high-dose aflibercept after treatment-refractory nAMD similarly found stable visual acuity alongside anatomical improvement, reinforcing that switching anti-VEGF regimens—whether to a biosimilar or a reformulated originator—can maintain disease control without compromising outcomes.²

“Switching to aflibercept 8 mg in treatment-refractory nAMD eyes in a real-world setting was associated with increased treatment durability, modest anatomical improvements, stable BCVA, and a favorable short-term safety profile,” wrote the researchers of the UK study. “These early outcomes support the use of aflibercept 8 mg in eyes with high treatment burden and persistent disease activity within routine clinical practice. Importantly, no serious ocular adverse events were observed despite the higher injection volume compared to conventional anti-VEGF agents. Further prospective studies with larger sample sizes and longer follow-up are warranted to confirm the long-term efficacy, durability, and safety of aflibercept 8 mg.”

Managed Care Implications

For payers and health systems, these findings offer real-world reassurance that switching established patients to the aflibercept biosimilar SB15 is unlikely to compromise anatomical or visual outcomes across the most common retinal indications, supporting formulary strategies that favor biosimilar adoption to reduce per-injection costs. The low serious adverse event rate further supports confidence in safety-driven step therapy or mandatory-switch policies, although plans should continue to monitor longer-term durability data, as follow-up in this cohort was limited to roughly 5 months.¹

“These findings support the real-world effectiveness and safety of SB15 (Afilivu) in both treatment-naïve and switching populations across diverse retinal diseases,” wrote the researchers of the study.

References

1. Song JR, Jeon J, Baek SC, et al; International Retina Biosimilar Study Group (Inter BIOS Group). Aflibercept biosimilar use and real-world outcomes in various retinal diseases: the AURA Korea study. Sci Rep. 2026. doi:10.1038/s41598-026-52212-4
2. Musadiq M, Musadiq M, Latif F, et al. Early real-world outcomes of switching to 8 mg aflibercept for neovascular age-related macular degeneration in the United Kingdom. Life (Basel). 2025;15(6):903. doi:10.3390/life15060903