Sandoz Expands Enzeevu® Label with FDA Approval for Retinal Indications

Sandoz Group AG has received FDA approval to extend the label for Enzeevu® (aflibercept-abzv) to encompass multiple retinal conditions. Originally approved for neovascular age-related macular degeneration (nAMD) in 2024, Enzeevu® now includes macular edema following retinal vein occlusion, diabetic retinopathy, and diabetic macular edema. This development offers a biosimilar option for more patients with these retinal diseases.

The launch of Enzeevu® in the US is projected for Q4 2026. Sandoz President of North America, Keren Haruvi, highlighted that over 30 million Americans face retinal diseases that could lead to vision loss. The company remains focused on providing biologic medicines sustainably and affordably while maintaining a robust portfolio of biosimilars.

This approval bolsters Sandoz’s presence in ophthalmology and aligns with its strategic aim to tap into a growing biosimilar market, anticipated to reach USD 320 billion in the next decade.