Biologic facts
BrandBenlysta (Belimumab)
No biosimilar to Benlysta is licensed. The 12-year reference exclusivity date of 03/2023 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Benlysta was first approved by the FDA in 2011; the application holder is Glaxosmithkline LLC.
The most recent FDA recall on record is a Class II recall dated 04/21/2025.
Holder Glaxosmithkline LLCApproved 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
- 03/202312-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 Benlysta profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- Latest recall
- 04/21/2025Class II, Belimumab, Mckesson Medical-Surgical Inc. Corporate Office FDA enforcement
04Product
- Application holder
- Glaxosmithkline LLC 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.