FDA Approves Enzeevu (aflibercept-abzv), a Biosimilar to Eylea
FDA approves Enzeevu (aflibercept-abzv), a biosimilar to Eylea, for intravitreal injection in patients with neovascular age-related macular degeneration (nAMD). Enzeevu is a key biosimilar value driver for Sandoz, extending its leading US ophthalmology portfolio. The approval is based on comprehensive analytical, preclinical, and clinical data from the Mylight study.
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The FDA approved Pavblu (aflibercept-ayyh), the fifth Eylea biosimilar, for treating retinal conditions. Pavblu, developed by Amgen, showed no clinically meaningful differences in a phase 3 study compared to Eylea. Amgen and Regeneron are in a lawsuit over Pavblu's approval.
FDA approves Enzeevu (aflibercept-abzv), a biosimilar to Eylea, for intravitreal injection in patients with neovascular age-related macular degeneration (nAMD). Enzeevu is a key biosimilar value driver for Sandoz, extending its leading US ophthalmology portfolio. The approval is based on comprehensive analytical, preclinical, and clinical data from the Mylight study.
FDA approves Pavblu (aflibercept-ayyh), a biosimilar to Eylea, for treating neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).