FDA Approves Aflibercept Biosimilar Ahzantive

The Food and Drug Administration (FDA) has approved Ahzantive^® (aflibercept-mrbb), a biosimilar to Eylea^® (aflibercept).

Ahzantive is a vascular endothelial growth factor inhibitor indicated for the treatment of patients with: neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

A biosimilar is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved biological product with no clinically meaningful differences in safety and efficacy from the reference product. The approval of Ahzantive was supported by data from the phase 3 MAGELLAN-AMD study (ClinicalTrials.gov Identifier: NCT04522167), which compared aflibercept-mrbb to Eylea in patients with neovascular age related macular degeneration.

Findings showed the study met its primary endpoint demonstrating comparable efficacy between the biosimilar and reference product based on the change from baseline in best corrected visual acuity after 8 weeks. With regard to safety and immunogenicity, no clinically relevant differences were observed between the treatment groups. 

Ahzantive is supplied as a 2 mg solution in a single-dose vial. The treatment is administered as an intravitreal injection.

This article originally appeared on MPR