Biologic facts
BrandLibtayo (Cemiplimab)
No biosimilar to Libtayo is licensed. The 12-year reference exclusivity date of 09/2030 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Libtayo was first approved by the FDA in 2018; the application holder is Regeneron Pharmaceuticals, Inc.
The most recent FDA recall on record is a Class II recall dated 07/28/2026.
Holder Regeneron Pharmaceuticals, Inc.Approved 2018
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
- 09/203012-year estimate from first approval Purple Book
02Competition
- Biosimilars
- No biosimilar approved 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 Libtayo profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- Latest recall
- 07/28/2026Class II, Cemiplimab-Rwlc, Regeneron Pharmaceuticals Inc FDA enforcement
04Product
- Application holder
- Regeneron Pharmaceuticals, Inc. Purple Book
- First approved
- 2018 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.