The United States Food and Drug Administration (FDA) has approved an expanded label for Enzeevu (aflibercept-abzv, Sandoz), to include multiple retinal indications. Enzeevu was originally approved by the FDA for the treatment of neovascular (wet) age-related macular degeneration (nAMD) in August 2024.2
The most recent approval expands the Enzeevu label indications to include macular oedema following retinal vein occlusion (RVO), diabetic retinopathy (DR), and diabetic macular oedema (DMO), along with the previously approved indication of nAMD. This expansion offers retina specialists a clinically-proven aflibercept biosimilar option to treat more patients across these retinal diseases.
approval expands the Enzeevu label indications to include macular oedema following retinal vein occlusion, diabetic retinopathy, and diabetic macular oedema
Sandoz has a global portfolio comprising 13 biosimilars and a further 27 assets in various stages of development.
This approval strengthens the company’s position in ophthalmology, following the acquisition of the US biosimilar Cimerli (ranibizumab-eqrn) in 2024 and the European launch of Afqlir (aflibercept) in 2025. It also represents another step towards the overall strategic objective of capitalising on a projected ~USD 320 billion biosimilar market opportunity over the next 10 years.3
Enzeevu is expected to launch in the US in the fourth quarter of 2026, or earlier under certain circumstances.
References
1. CDC. Vision and eye health surveillance systems. Available at: ddt-vehss.cdc.gov/LP?Level1=Age-related+Macular+Degeneration+(AMD)&Level2=AMD+Prevalence&Level3=VEHSS+Modeled+Estimate:+Agerelated+Macular+Degeneration+(AMD)&Level4=Prevalence+of+AMD&LocationId=&DataSourceId=PREV&GSDataSourceId=&GSLocationId=&RiskFactorSubCatId=&IndicatorId=QAMDM~R3_ALL&ShowFootnotes=true&View=NationalChartTable&CompareViewYear=1&CompareId=&CompareId2=&YearId=YR11&ResponseId=R3_ALL&AgeId=AGE40PLUS&GenderId=GALL&RaceId=ALLRACE&RiskFactorId=RFPERS&RiskFactorResponseId=RFTOT&DataValueTypeId=CRDPREV&MapClassifierId=quantile&MapClassifierCount=7&CountyFlag=N [accessed: Feb 2026]
2. Sandoz. Sandoz receives FDA approval for Enzeevu (aflibercept-abzv), further strengthening US biosimilar position. Available at: sandoz.com/sandoz-receives-fda-approval-enzeevutm-aflibercept-abzv-further-strengthening-us-biosimilar [accessed: Feb 2026]
3. Sandoz data on file.
