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Enbrel

Etanercept

An anti-TNF biologic for rheumatoid arthritis and psoriasis.

Generic name
Etanercept
Brand name
Enbrel
Route
Subcutaneous
Marketed by
Amgen (Immunex)
FDA pharmacologic class
Tumor Necrosis Factor Blocker; Tumor Necrosis Factor Receptor Blocking Activity
First FDA approval
2 Nov 1998

Where Etanercept is approved

All regulators →

Of the three regulators tracked here, the first to approve Etanercept was the US, on 2 Nov 1998. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
2 Nov 1998
Enbrel
BLA103795 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
2 Feb 2000
Enbrel
EMA product page
First centralised authorisation
CACanada (Health Canada)
1 Dec 2000
Enbrel
Notice of Compliance 1134
First new-drug NOC

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 Etanercept

All medicines →
ENNHS England
£14k
26 items dispensed, Aug 2025 to Jul 2026
+78% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$1.10bn
140,529 prescriptions in 2025 · Enbrel
+4% on 2024
Amount Medicaid reimbursed, before rebates

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 Etanercept works

All drug targets →
  • TNF-alpha inhibitor Inhibitor
    Target: TNF tumor necrosis factor
    ChEMBL only
Diseases it has been tested for in clinical trials, by furthest phase
  • AnorexiaPhase 3
  • SciaticaPhase 3
  • Stevens-Johnson syndromePhase 3
  • Acute graft versus host diseasePhase 3
  • Chronic kidney diseasePhase 3
  • Enthesitis-related juvenile idiopathic arthritisPhase 3
  • Extended oligoarticular juvenile idiopathic arthritisPhase 3
  • Myocardial ischemiaPhase 3
  • Palmoplantar pustulosisPhase 3
  • PneumoniaPhase 3
57 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201572, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6789, 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 Etanercept

All NICE appraisals →

NICE, which decides whether the NHS in England should fund new medicines, has published 13 technology appraisals of Etanercept. 9 are current, and 9 of these recommend it for at least some patients. 4 older appraisals were replaced or withdrawn.

AppraisalNICE recommendationPublishedStatus
Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed
NICE TA715
Optimised Not recommended14 Jul 2021Current
Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people
NICE TA455
Optimised12 Jul 2017Current
TNF-alpha inhibitors for treating active ankylosing spondylitis and non-radiographic axial spondyloarthritis
NICE TA383
Recommended1 Feb 2016Current
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
Optimised26 Jan 2016Current
Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
NICE TA373
Recommended16 Dec 2015Current
Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
NICE TA195
Optimised Recommended25 Aug 2010Current
Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
NICE TA199
Recommended25 Aug 2010Current
Etanercept and efalizumab for treating moderate to severe plaque psoriasis
NICE TA103
Optimised Recommended26 Jul 2006
Updated 1 Sep 2009
Current

See all 9 appraisals →

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 Etanercept

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 23 products on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • EU
    European Union: Enbrel, Benepali (biosimilar), Erelzi (biosimilar), Fubelv (biosimilar), Nepexto (biosimilar)
    EMA product information: package leaflet and summary of product characteristics in every EU language.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-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 Etanercept

ATC code
L04AB01
ChEMBL
CHEMBL1201572
DrugBank
DB00005
CAS number
185243-69-0
FDA UNII
OP401G7OJC
Wikidata
Q415343
Wikipedia
Etanercept

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 Enbrel is used for

Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) ( 1.1 ) Psoriatic Arthritis (PsA) ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Plaque Psoriasis (PsO) ( 1.5 ) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older ( 1.2 ) Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) ( 1.6 ) Plaque Psoriasis, 4 years of age or older ( 1.5 ) 1.1 Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone. 1.2 Polyarticular Juvenile Idiopathic Arthritis Enbrel is indicated for reducing signs and…

How it works

12.1 Mechanism of Action TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. It plays an important role in the inflammatory processes of RA, polyarticular JIA, PsA, and AS and the resulting joint pathology. In addition, TNF plays a role in the inflammatory process of PsO. Elevated levels of TNF are found in involved tissues and fluids of patients with RA, JIA, PsA, AS, and PsO. Two distinct receptors for TNF (TNFRs), a 55 kilodalton protein (p55) and a 75 kilodalton protein (p75), exist naturally as monomeric molecules on cell surfaces and in soluble forms. Biological activity of TNF is dependent upon binding to either cell surface TNFR. Etane…

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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.

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 9 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.