Simponi
An injectable or intravenous biological therapy used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Where Golimumab is approved
All regulators →Of the three regulators tracked here, the first to approve Golimumab was Canada, on 7 Apr 2009. It is approved in 3 of the 3 regulators tracked here.
- 1 FDA-approved biosimilar, 1 interchangeable: Immgolis
- 1 EU safety letter (DHPC), latest: quality defect for Simponi, 9 Aug 2023
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Golimumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Golimumab works
All drug targets →- TNF-alpha inhibitor InhibitorTarget: TNF tumor necrosis factorChEMBL only
- Psoriasis-related juvenile idiopathic arthritisPhase 3
- Inflammatory bowel diseasePhase 2/3
- Behcet diseasePhase 2
- Crohn diseasePhase 2
- AsthmaPhase 2
- Prostate cancerPhase 2
- SarcoidosisPhase 2
- Type 1 diabetes mellitusPhase 2
- UveitisPhase 2
- Autoimmune inner ear diseasePhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201833, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6776, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Golimumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 8 technology appraisals of Golimumab. 6 are current, and 6 of these recommend it for at least some patients. 2 older appraisals were replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Golimumab for treating active non-radiographic axial spondyloarthritis NICE TA497 | Recommended | 10 Jan 2018 | Current |
| TNF-alpha inhibitors for treating active ankylosing spondylitis and non-radiographic axial spondyloarthritis NICE TA383 | Recommended | 1 Feb 2016 | Current |
| Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed NICE TA375 | Optimised | 26 Jan 2016 | Current |
| Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy NICE TA329 | Recommended | 25 Feb 2015 | Current |
| Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs NICE TA225 | Optimised | 22 Jun 2011 | Current |
| Golimumab for the treatment of psoriatic arthritis NICE TA220 | Recommended | 27 Apr 2011 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Golimumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 9 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Golimumab
- ATC code
- L04AB06
- ChEMBL
- CHEMBL1201833
- DrugBank
- DB06674
- CAS number
- 476181-74-5
- FDA UNII
- 91X1KLU43E
- Wikidata
- Q413879
- Wikipedia
- Golimumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Simponi is used for
Golimumab (Simponi) is an injectable or intravenous biological therapy used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. It belongs to the TNF blocker class.
Related clinical trials recruiting now
Compare Simponi with
Explore more
How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 5 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.