Biologic facts
BrandEylea (Aflibercept)
6 aflibercept biosimilars from 6 makers are licensed, 2 of them interchangeable. FDA lists reference exclusivity to 05/18/2024; the Purple Book does not list patents, which can protect a biologic longer.
Eylea was first approved by the FDA in 2011; the application holder is Regeneron Pharmaceuticals, Inc.
The most recent FDA recall on record is a Class II recall dated 05/15/2024.
Holder Regeneron Pharmaceuticals, Inc.Approved 2011
01Exclusivity
When biosimilar competition can legally begin. The Purple Book lists reference exclusivity but not patents, which can protect a biologic longer.
- Patents
- Not listed in the Purple Book Purple Book
- Reference exclusivity
- 05/18/2024 Purple Book
02Competition
- Biosimilars
- 6 biosimilars from 6 makers Purple Book
- Interchangeable
- 2 Purple Book
Every makerEach licensed product and biosimilar maker.
PrescribersWho prescribes it, from Medicare data.
Spend and safetyMedicare Part B spend and safety reports.
Available in the full Eylea profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- Latest recall
- 05/15/2024Class II, Aflibercept, Regeneron Pharmaceuticals Inc FDA enforcement
04Product
- Application holder
- Regeneron Pharmaceuticals, Inc. Purple Book
- First approved
- 2011 Purple Book
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.