FDA Approves Yesafili (aflibercept-jbvf), an Interchangeable Biosimilar to Eylea

the U.S. Food and Drug Administration (FDA) granted approval for Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept products function by inhibiting vascular endothelial growth factor (VEGF), which hinders abnormal blood vessel growth in the eye. By blocking VEGF, these products can slow down or reduce damage to the retina and help preserve vision

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Browse Pharma

23 mai 2024

On May 20, 2024, the U.S. Food and Drug Administration (FDA) granted approval for Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept products function by inhibiting vascular endothelial growth factor (VEGF), which hinders abnormal blood vessel growth in the eye. By blocking VEGF, these products can slow down or reduce damage to the retina and help preserve vision.

Additionally, the FDA also approved Opuviz (aflibercept-yszy), another interchangeable biosimilar to Eylea.

Both Yesafili and Opuviz are used to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

To treat patients with these conditions, both Yesafili and Opuviz are administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/mL) injectable solution. The dosing regimens are recommended in the labeling.

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