………….. catching up on FDA Approvals
The FDA recently approved a biosimilar….. meh news…… huh?
But wait….. on the same day the FDA approved two biosimilars….. big news?
The more interesting news is that the approval was for two different biosimilars….. and….. both have the same indication!…. perhaps that’s the biggest news.
The approvals included….. Yesafili (aflibercept-jbvf) from Biocon Biologics and Opuviz (aflibercept-yszy) from Biogen, Samsung Bioepis with an indication for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD); macular edema following retinal vein occlusion (RVO), diabetic macular edema, and diabetic retinopathy.
Both therapies are the first interchangeable biosimilars to reference product Eylea (aflibercept) from Regeneron. Yesafili and Opuviz are both vascular endothelial growth factor (VEGF) inhibitors and each is administered by intravitreal injection every 4 weeks for the first 5 injections, followed by 2 mg (0.05 mL of 40 mg/mL solution) once every 8 weeks.
Regeneron recorded U.S. sales of $5.72 billion from Eylea in 2023. Regeneron’s reference product, Eylea (intravitreal solution (40 mg/mL), is around $2,000.
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