Biologic facts
BrandSimponi (Golimumab)
2 golimumab biosimilars from 1 maker are licensed, 2 of them interchangeable. The 12-year reference exclusivity date of 04/2021 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Simponi was first approved by the FDA in 2009; the application holder is Janssen Biotech, Inc.
The latest NADAC for SIMPONI 50 MG/0.5 ML PEN INJEC is $12,901.13 per mL (as of 10/28/2026).
Holder Janssen Biotech, Inc.Approved 2009
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
- 04/202112-year estimate from first approval Purple Book
02Competition
- Biosimilars
- 2 biosimilars from 1 maker 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 Simponi profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $12,901.13 per mLSIMPONI 50 MG/0.5 ML PEN INJEC, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Janssen Biotech, Inc. Purple Book
- First approved
- 2009 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.