………….. catching up on FDA Approvals
Here’s what we wrote back in July…..
The FDA recently approved a biosimilar….. big news…… huh?
But wait….. on the same day the FDA approved two biosimilars….. bigger news?
The earlier approvals included….. Yesafili (aflibercept-jbvf) from Biocon Biologics) and Opuviz(aflibercept-yszy) from Biogen, Samsung Bioepis.
BUT WAIT….. only weeks later the FDA has approved three more biosimilars for the same reference product! This has to be a record.
Shortly after the approvals originally noted, the FDA approved biosimilar Ahzantive (aflibercept-mrbb) referencing Eylea (aflibercept) from Formycon in late July for age-related macular degeneration.
Then the FDA approved Enzeevu (aflibercept-abzv) in August 2024.
Then the FDA approved another in mid September, Pavblu (aflibercept-ayyh) from Amgen also referencing Eylea .
The therapies are interchangeable biosimilars to reference product Eylea (aflibercept) from Regeneron. Ahzantive and Pavblu join Yesafili and Opuviz as 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 Eylea intravitreal solution (40 mg/mL) is around $2,000.
We think we might need a bigger basket!
