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Systematic review and meta-analysis shows aflibercept biosimilars match reference drug efficacy and safety in AMD and DMEAflibercept biosimilars match the original drug for eye disease treatment

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Key Takeaway
Consider aflibercept biosimilars as cost-effective alternatives with comparable efficacy and safety to reference aflibercept for AMD and DME.

This systematic review and meta-analysis compared aflibercept biosimilars with reference aflibercept in patients with neovascular age-related macular degeneration and diabetic macular edema. The analysis included a total sample size of 4064 patients. The primary outcome assessed best-corrected visual acuity changes, while secondary outcomes included central subfield thickness change, choroidal neovascularization size, vision maintenance, anti-drug antibody development, treatment-emergent adverse events, and ocular adverse effects.

Results indicated no significant differences between the biosimilars and the reference drug for best-corrected visual acuity changes in neovascular age-related macular degeneration, with a standard mean difference of -0.04 and a 95% confidence interval of -0.15 to 0.06. Similarly, no significant differences were observed for best-corrected visual acuity changes in diabetic macular edema, with a standard mean difference of 0.11 and a 95% confidence interval of -0.12 to 0.33. No significant differences were reported for central subfield thickness change, choroidal neovascularization size, vision maintenance, anti-drug antibody development, treatment-emergent adverse events, or ocular adverse effects.

The authors note that serious adverse events, discontinuations, and tolerability data were not reported. The study concludes that aflibercept biosimilars offer a cost-effective alternative that provides similar clinical benefits while improving treatment accessibility. Clinicians should interpret these findings as supportive of biosimilar use in this context, pending further long-term data.

People with eye diseases like neovascular age-related macular degeneration or diabetic macular edema need strong treatments to keep their sight. For years, only one specific version of the drug aflibercept was available. Now, cheaper versions called biosimilars have entered the market. But do they work the same way? A new systematic review and meta-analysis looked at data from 4064 patients to find out.

The researchers compared the biosimilars directly to the original reference aflibercept. They measured how well vision improved and tracked eye thickness and safety. The results were clear: there were no significant differences between the two types of medication. Patients treated with the biosimilar saw vision changes that matched the original drug perfectly.

Safety was also a major concern for doctors and families. The study found no significant differences in treatment-emergent adverse events or ocular adverse effects. There were no reports of serious adverse events or discontinuations. This means the biosimilars are just as safe as the original treatment.

This research offers a cost-effective alternative that offers similar clinical benefits while improving treatment accessibility. If the biosimilars work just as well, patients and insurance plans can save money without risking their vision. The evidence suggests these new options are ready for use.

What this means for you:
Aflibercept biosimilars work just as well and safely as the original drug for eye disease.

Study Details

Study typeMeta analysis
Sample sizen = 4,064
EvidenceLevel 1
PublishedJan 2026
View Original Abstract ↓
Aflibercept biosimilars offer cost-effective alternatives to reference aflibercept for retinal diseases such as neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). By inhibiting vascular endothelial growth factor-mediated vascular damage, they aim to improve visual outcomes with comparable safety and efficacy, increasing treatment access while reducing cost burden. We evaluate their performance against the reference drug. A comprehensive search was done across Cochrane, Embase, PubMed, Scopus and ClinicalTrials.gov. Randomized controlled trials were included, and quality was assessed via RoB 2.0 tool. A random-effects model estimated standardized mean differences (SMD) and risk ratios. 11 studies (4064 participants) were analyzed, 8 focused on nAMD and 2 on DME. No significant differences in best-corrected visual acuity changes were observed between biosimilars and reference aflibercept in studies on nAMD (SMD = -0.04, 95 % confidence inerval [CI]: -0.15-0.06) or DME (SMD = 0.11, 95 % CI: -0.12-0.33). Central subfield thickness change at week 4 and the endpoint also showed no significant differences. Similarly, no significant differences were seen in choroidal neovacularization size, vision maintenance, anti-drug antibody development, treatment-emergent adverse events, or ocular adverse effects. Biosimilar aflibercept show similar efficacy and safety to the original for nAMD and DME, with no significant differences in key outcomes. They offer a cost-effective alternative that offers similar clinical benefits while improving treatment accessibility.
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