Prescription medicine
Golimumab Brand names: Simponi
Golimumab (Simponi) is a prescription medicine with an FDA approval on record since 2009. No generic is listed; pharmacies paid $12,890.32 per mL (Simponi 50 mg/0.5 mL pen injec) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the golimumab FDA label on DailyMed (effective September 9, 2025, Janssen Biotech, Inc.); the BLA 125289 record on Drugs@FDA; every golimumab label on DailyMed.
Highlights of the record
FDA label of September 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 ). Perform test for latent TB; if positive, start treatment for TB prior to starting SIMPONI ARIA ( 5.1 ). Monitor all patients for active TB during treatment, even if initial latent TB test is negative ( 5.1 ). Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI ARIA is a member ( 5.2 ). SERIOUS INFECTIONS Patients treated with SIMPONI ARIA 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 SIMPONI ARIA if a patient develops a serious infection. Reported infections with TNF blockers, of which SIMPONI ARIA is a member, include: Active tuberculosis, including reactivation of latent tuberculosis. […]
Used for
From the label: indications and usageSIMPONI 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 year
Forms and strengths
- 50 mg/4ml
- 50 mg/.5ml
- 100 mg/ml
Injection (solution); solution.
On the market
- Earliest approval on file
- April 24, 2009 Simponi, Centocor Ortho Biotech Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $12,890.32 per mL Simponi 50 mg/0.5 mL pen injec
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 12,308 through July 30, 2026
What is golimumab used for?
From the label: indications and usageSIMPONI 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 years of age and older ( 1.4 ) 1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.2 Psoriatic Arthritis (PsA) SIMPONI ARIA is indicated for […]
Conditions named in the indications of golimumab's FDA labels, with every medicine labeled for each:
From other golimumab labelsCrohn's disease and ulcerative colitis: Ulcerative Colitis SIMPONI is indicated for the treatment of adults and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis.
FDA pharmacologic class: Tumor Necrosis Factor Blocker.
Source: FDA drug label (SIMPONI ARIA), Janssen Biotech, Inc., effective September 9, 2025 (SPL set 9e260a47-55af-4c92-8d88-a86ccc767fff), via openFDA; the full label on DailyMed
What does the patient leaflet for golimumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SIMPONI ARIA?SIMPONI ARIA is a medicine that affects your immune system. SIMPONI ARIA can lower the ability of your immune system to fight infections. Some people have serious infections while receiving SIMPONI ARIA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body. Some people have died from these serious infections. Your doctor should test you for TB and hepatitis B before starting SIMPONI ARIA. Your doctor should monitor you closely for signs and symptoms of TB during treatment with SIMPONI ARIA. You should not start receiving SIMPONI ARIA if you have any kind of infection unless your doctor tells you to. Before receiving SIMPONI ARIA, tell your doctor if you: think you have an infection or have symptoms of an infection such as: fever, sweat, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired are being treated for an infection. get a lot of infections or have infections that keep coming back. have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections. have TB, or have been in close contact with someone with TB. live, have lived, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may happen or become more severe if you use SIMPONI ARIA. […]
Source: FDA drug label (SIMPONI ARIA), Janssen Biotech, Inc., effective September 9, 2025 (SPL set 9e260a47-55af-4c92-8d88-a86ccc767fff), via openFDA; the full label on DailyMed
Is there a generic for golimumab (Simponi)?
No generic golimumab is approved (Drugs@FDA, October 8, 2026).
- 2009 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for golimumab (Simponi)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $12,890.32 per mL (Simponi 50 mg/0.5 mL pen injec), up 4% from $12,352.93 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Simponi 50 mg/0.5 mL pen injec (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Simponi 50 mg/0.5 mL pen injec | Brand | $12,890.32 per mL | $6,445.16 per single-dose pen | +4% |
| Simponi 50 mg/0.5 mL syringe | Brand | $12,977.24 per mL | $6,488.62 per single-dose syringe | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the golimumab label say about other medicines?
The golimumab label names 9 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abatacept | drug interactions | DRUG INTERACTIONS Biologics, including abatacept and anakinra: Increased risk of serious infections ( 5.1 , 5.6 , 5.7 , 5.8 , 7.2 ). |
| Anakinra | drug interactions | DRUG INTERACTIONS Biologics, including abatacept and anakinra: Increased risk of serious infections ( 5.1 , 5.6 , 5.7 , 5.8 , 7.2 ). |
| Azathioprine | warnings and precautions | Almost all these patients had received treatment with azathioprine (AZA) or 6-mercaptopurine (6–MP) concomitantly with a TNF-blocker at or prior to diagnosis. |
| Cyclophosphamide | warnings and precautions | In controlled trials of other TNF-blockers in patients at higher risk for malignancies (e.g., patients with chronic obstructive pulmonary disease [COPD], patients with Wegener's granulomatosis treated with concomitant cyclophosphamide) a greater portion of malignancies occurred in the TNF-blocker group compared to the … |
| Cyclosporine | drug interactions | Upon initiation or discontinuation of SIMPONI ARIA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Rituximab | drug interactions | A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF-blocker. |
| Theophylline | drug interactions | Upon initiation or discontinuation of SIMPONI ARIA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
| Warfarin | drug interactions | Upon initiation or discontinuation of SIMPONI ARIA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
Source: FDA drug label (SIMPONI ARIA), Janssen Biotech, Inc., effective September 9, 2025 (SPL set 9e260a47-55af-4c92-8d88-a86ccc767fff), via openFDA; the full label on DailyMed
What do FAERS reports show for golimumab?
The FDA Adverse Event Reporting System holds 12,308 reports that list golimumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,587 are coded as a death and 4,284 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as golimumab?
8 other medicines are given the same way (subcutaneous) and in the same FDA class as golimumab or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Adalimumab | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | none listed | $1,587.82 per mL 40 mg/0.4 mL | No current entry |
| Etanercept | Rheumatoid arthritis | none listed | $2,084.14 per mL 25 mg/0.5 mL syringe | No current entry |
| Certolizumab | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | none listed | $6,094.02 per syringe 2x200 mg/mL syringe kit | No current entry |
| Methotrexate | Rheumatoid arthritis | none listed | $289.37 per mL 25 mg/0.5 mL autoinj | In shortage |
| Tocilizumab | Rheumatoid arthritis | none listed | $821.00 per mL 162 mg/0.9 mL autoinjct | No current entry |
| Sarilumab | Rheumatoid arthritis | none listed | $2,075.30 per mL 200 mg/1.14 mL pen injection | No current entry |
| Abatacept | Rheumatoid arthritis | none listed | $1,469.23 per mL 125 mg/mL syringe | No current entry |
| Adalimumab-aacf | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does golimumab compare with medicines for the same use?
3 side-by-side pages set golimumab beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to golimumab
- 8 medicines for the same use
- Other TNF blockers
- the pharmacologic class, with prices and generics
- Golimumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other