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Two medicines, side by side

Etanercept vs golimumab

Etanercept and golimumab are both labeled for rheumatoid arthritis. Drugs@FDA records approvals of etanercept since 1998 and of golimumab since 2009. Pharmacies paid $2,084.14 per mL (Enbrel 25 mg/0.5 mL syringe) and $12,890.32 per mL (Simponi 50 mg/0.5 mL pen injec) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Etanercept, “TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.”; Golimumab, “Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα.”

Check it at the source: the etanercept FDA label on DailyMed (effective May 11, 2026); the golimumab FDA label on DailyMed (effective September 9, 2025).

Highlights of the etanercept record

Etanercept (Enbrel) · label of May 11, 2026

Boxed warning

SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. ( 5.1 ) Enbrel should be discontinued if a patient develops a serious infection or sepsis during treatment.

Used for

From the label: indications

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 ) […]

On the market

Earliest approval on file
November 2, 1998
Generic labelers
none listed
Pharmacy cost
$2,084.14 per mL

Supply and safety

Shortage
No current entry
Recalls
0

Highlights of the golimumab record

Golimumab (Simponi) · label of September 9, 2025

Boxed warning

SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ARIA ( 5.1 ). Discontinue SIMPONI ARIA if a patient develops a serious infection or sepsis ( 5.1 ).

Used for

From the label: indications

SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate ( 1.1 ) Active Psoriatic Arthritis (PsA) in patients 2 years of age and older ( 1.2 ) Adult patients with active Ankylosing Spondylitis (AS) ( 1.3 ) Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 […]

On the market

Earliest approval on file
April 24, 2009
Generic labelers
none listed
Pharmacy cost
$12,890.32 per mL

Supply and safety

Shortage
No current entry
Recalls
0

Source: FDA drug labels via openFDA (Etanercept label of May 11, 2026, Golimumab label of September 9, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do etanercept and golimumab differ on the record?

How each works, in its label's words: Etanercept, “TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.”; Golimumab, “Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα.”

Both are in FDA's class tumor necrosis factor blockers.

Half-life, in each label's words: Etanercept, “12.3 Pharmacokinetics After administration of 25 mg of Enbrel by a single SC injection to 25 patients with RA, a mean ± …”; Golimumab, “The mean terminal half-life was estimated to be 12 ± 3 days in healthy subjects and the mean terminal half-life in RA …”

Both labels carry a boxed warning; the records quote them.

EtanerceptGolimumab
Labeled forRheumatoid arthritis, PsoriasisRheumatoid arthritis, Crohn's disease and ulcerative colitis
Pharmacologic classTumor Necrosis Factor BlockerTumor Necrosis Factor Blocker
How it works (label)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.Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα.
Half-life (label)12.3 Pharmacokinetics After administration of 25 mg of Enbrel by a single SC injection to 25 patients with RA, a mean ± standard deviation half-life of 102 ± 30 hours was observed with a clearance of 160 ± 80 mL/hr.The mean terminal half-life was estimated to be 12 ± 3 days in healthy subjects and the mean terminal half-life in RA patients was 14 ± 4 days.
Earliest approval on file (Drugs@FDA)November 2, 1998April 24, 2009
First generic approvednonenone
Generic labelers (NDC)none listednone listed
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$2,084.14 per mL (Enbrel 25 mg/0.5 mL syringe)$12,890.32 per mL (Simponi 50 mg/0.5 mL pen injec)
12-month price change+5%+4%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded00
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)595,12912,308
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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