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Two medicines, side by side

Adalimumab vs golimumab

Adalimumab and golimumab are both labeled for crohn's disease and ulcerative colitis and rheumatoid arthritis. Drugs@FDA records approvals of adalimumab since 2002 and of golimumab since 2009. Pharmacies paid $1,587.82 per mL (Adalimumab-adaz(cf) pen 40 mg/0.4 mL) and $12,890.32 per mL (Simponi 50 mg/0.5 mL pen injec) (NADAC, October 7, 2026); the strengths differ and one is a brand and one a generic, so the two prices are not like for like. How each works, in its label's words: Adalimumab, “Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors.”; 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 adalimumab FDA label on DailyMed (effective October 21, 2025); the golimumab FDA label on DailyMed (effective September 9, 2025).

Highlights of the adalimumab record

Adalimumab (Humira) · label of October 21, 2025

Boxed warning

SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including Adalimumab-adaz, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue Adalimumab-adaz if a patient develops a serious infection or sepsis.

Used for

From the label: indications

Adalimumab-adaz is a tumor necrosis factor (TNF)-blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. […]

On the market

Earliest approval on file
December 31, 2002
Generic labelers
none listed
Pharmacy cost
$1,587.82 per mL

Supply and safety

Shortage
No current entry
Recalls
1

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 (Adalimumab label of October 21, 2025, Golimumab label of September 9, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do adalimumab and golimumab differ on the record?

How each works, in its label's words: Adalimumab, “Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors.”; 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: Adalimumab, “The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies.”; 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.

AdalimumabGolimumab
Labeled forRheumatoid arthritis, Crohn's disease and ulcerative colitis, PsoriasisRheumatoid arthritis, Crohn's disease and ulcerative colitis
Pharmacologic classTumor Necrosis Factor BlockerTumor Necrosis Factor Blocker
How it works (label)Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement.Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα.
Half-life (label)The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies.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)December 31, 2002April 24, 2009
First generic approvednonenone
Generic labelers (NDC)none listednone listed
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$1,587.82 per mL (Adalimumab-adaz(cf) pen 40 mg/0.4 mL)$12,890.32 per mL (Simponi 50 mg/0.5 mL pen injec)
12-month price change-0.3%+4%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded10
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)712,30812,308
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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