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US Eylea Biosimilar Approvals Set Up Competition On Aflibercept

Both Biocon And Biogen Receive Interchangeability Designations For Ophthalmic Treatment

 
• By Dave Wallace

Biocon and Biogen have received simultaneous US approvals for aflibercept biosimilar rivals to Eylea, with both products also receiving interchangeability designations. However, launches may have to wait while IP issues are resolved.

US flag reflected in eye
Biocon and Biogen have US approvals for aflibercept • Source: Shutterstock

Approvals for two Eylea (aflibercept) biosimilars have been granted by the US Food and Drug Administration, with both products also receiving interchangeability designations.

Biocon’s Yesafili (aflibercept-jbvf) and Biogen’s Samsung Bioepis-partnered Opuviz (aflibercept-yszy) have been approved by the FDA to treat neovascular (wet) age-related macular degeneration; macular edema following retinal vein occlusion; diabetic macular

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