Biosimilar anti-VEGF matched reference ranibizumab and aflibercept for vision and safety

Design

Systematic review and meta-analysis of randomised and observational studies

Population

25 studies of biosimilar vs reference anti-VEGF in macular degeneration, macular oedema, vein occlusion and polypoidal disease

Primary outcome

Visual acuity, retinal thickness and adverse events

Effect

No significant differences in any outcome over 12 to 63.6 weeks

This systematic review and meta-analysis pooled 25 studies, randomised and observational, comparing biosimilar with reference anti-VEGF injections in neovascular macular degeneration, diabetic macular oedema, retinal vein occlusion and polypoidal choroidal vasculopathy, with follow-up from 12 to about 64 weeks.

There were no significant differences in final visual acuity, change in acuity, retinal thickness or adverse events. Results held in randomised trials and observational studies separately, by disease, and for ranibizumab and aflibercept biosimilars. The authors rated the certainty of evidence moderate to high.

For Indian practice, where most patients pay for injections themselves and cost is a leading reason for undertreatment, this supports offering biosimilars as an equivalent choice. The gaps are long-term data beyond about a year and evidence for each individual product, which varies by manufacturer.

• Offer biosimilar anti-VEGF as an alternative to reference ranibizumab or aflibercept where cost limits treatment.
• Tell patients that vision and safety outcomes were similar up to about a year in pooled studies.
• Keep to the same treatment and monitoring schedule whichever product is used.
• Record the specific product and batch at each injection to support pharmacovigilance.
• Prioritise regular injections over brand: undertreatment is the bigger threat to vision.

Why it matters

Missed or delayed injections because of cost cause more vision loss than any difference between products shown here.

Don't overread it

Follow-up was mostly a year or less, and not every biosimilar product was studied individually.

The statistics, in plain English

No significant difference means the pooled estimates did not separate biosimilar from reference agents. Moderate-to-high certainty means further research is unlikely to change that picture much over this time frame.

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