Prescription medicine
Certolizumab Brand names: Cimzia
Certolizumab (Cimzia) is a prescription medicine with an FDA approval on record since 2008. No generic is listed; pharmacies paid $6,094.02 per syringe (Cimzia 2x200 mg/mL syringe kit) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the certolizumab FDA label on DailyMed (effective February 24, 2026, UCB, Inc.); the BLA 125160 record on Drugs@FDA; every certolizumab label on DailyMed.
Highlights of the record
FDA label of February 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. […]
Used for
From the label: indications and usageCIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy ( 1.1 ) Treatment of adults with moderately to severely active rheumatoid arthritis ( 1.2 ) Treatment of active polyarticular juvenile idiopathic arthritis
Forms and strengths
- 200 mg/ml
Injection (solution); kit.
On the market
- Earliest approval on file
- April 22, 2008 Cimzia, Ucb 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)
- $6,094.02 per syringe Cimzia 2x200 mg/mL syringe kit
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 0 Class I among all firms' recalls; latest May 8, 2026
- FAERS reports
- 116,513 through July 30, 2026
What is certolizumab used for?
From the label: indications and usageCIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy ( 1.1 ) Treatment of adults with moderately to severely active rheumatoid arthritis ( 1.2 ) Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older ( 1.3 ) Treatment of adult patients with active psoriatic arthritis. […]
Conditions named in the indications of certolizumab's FDA labels, with every medicine labeled for each:
From other certolizumab labelsPsoriasis: … signs of inflammation ( 1.6 ) Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or […]
FDA pharmacologic class: Tumor Necrosis Factor Blocker.
Source: FDA drug label (Cimzia), BLA125160 (Ucb Inc), as published by UCB, Inc., effective February 24, 2026 (SPL set b4c2c9dc-a0bb-4d64-a667-a67ebe88392d), via openFDA; the full label on DailyMed
What does the patient leaflet for certolizumab 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 CIMZIA?CIMZIA may cause serious side effects, including: CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker that can lower the ability of your immune system to fight infections. Some people who received CIMZIA have developed serious infections, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some of these serious infections have caused hospitalization and death. Your healthcare provider should test you for TB before starting CIMZIA. Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with CIMZIA. Before starting CIMZIA, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as: fever, sweat, or chills cough blood in phlegm warm, red, or painful skin or sores on your body burning when you urinate or urinate more often than normal muscle aches shortness of breath weight loss diarrhea or stomach pain feeling very tired are being treated for an infection. get a lot of infections or have infections that keep coming back. have diabetes, HIV-1 or a weak immune system. People with these conditions have a higher chance for infections. have tuberculosis (TB), or have been in close contact with someone with TB. were born in, live, have lived, or traveled to certain countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure. 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 risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis). […]
From the patient leaflet: How should I store CIMZIA?Keep CIMZIA in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze CIMZIA. Do not shake. Protect CIMZIA from light. Store CIMZIA in the carton it came in. Do not use CIMZIA if the medicine is expired. Check the expiration date on the prefilled syringe or carton. If needed, CIMZIA syringes may be stored at room temperature up to 77ºF (25ºC) in the original carton to protect from light for a single period of up to 7 days. After your CIMZIA syringe has been stored at room temperature, do not place back in refrigerator. Write the date removed from the refrigerator in the space provided on the carton and throw away (discard) if not used within the 7-day period. The CIMZIA prefilled syringe is made of glass. Do not drop or crush the syringe. Keep CIMZIA and all medicines out of the reach of children.
Source: FDA drug label (Cimzia), BLA125160 (Ucb Inc), as published by UCB, Inc., effective February 24, 2026 (SPL set b4c2c9dc-a0bb-4d64-a667-a67ebe88392d), via openFDA; the full label on DailyMed
Is there a generic for certolizumab (Cimzia)?
No generic certolizumab is approved (Drugs@FDA, October 8, 2026).
- 2008 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for certolizumab (Cimzia)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $6,094.02 per syringe (Cimzia 2x200 mg/mL syringe kit), up 5% from $5,821.73 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.
- Cimzia 2x200 mg/mL syringe kit (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cimzia 2x200 mg/mL syringe kit | Brand | $6,094.02 per syringe | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has certolizumab been recalled?
The FDA's Enforcement Report lists 1 recall naming certolizumab since 2026: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 8, 2026 | Class II | UCB Biosciences Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the certolizumab label say about other medicines?
The certolizumab label names 7 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 | An increased risk of serious infections has been seen in clinical studies of other TNF-blocking agents used in combination with anakinra or abatacept, with no added benefit. |
| Anakinra | drug interactions | An increased risk of serious infections has been seen in clinical studies of other TNF-blocking agents used in combination with anakinra or abatacept, with no added benefit. |
| Azathioprine | warnings and precautions | The potential risk of using a TNF blocker in combination with azathioprine or 6-MP should be carefully considered. |
| Etanercept | warnings and precautions | Drugs (Biological DMARDs) Serious infections were seen in clinical studies with concurrent use of anakinra (an interleukin-1 antagonist) and another TNF blocker, etanercept, with no added benefit compared to etanercept alone. |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Natalizumab | drug interactions | Therefore, the use of CIMZIA in combination with anakinra, abatacept, rituximab, or natalizumab is not recommended [see Warnings and Precautions (5.8) ]. |
| Rituximab | drug interactions | Therefore, the use of CIMZIA in combination with anakinra, abatacept, rituximab, or natalizumab is not recommended [see Warnings and Precautions (5.8) ]. |
Source: FDA drug label (Cimzia), BLA125160 (Ucb Inc), as published by UCB, Inc., effective February 24, 2026 (SPL set b4c2c9dc-a0bb-4d64-a667-a67ebe88392d), via openFDA; the full label on DailyMed
What do FAERS reports show for certolizumab?
The FDA Adverse Event Reporting System holds 116,513 reports that list certolizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,589 are coded as a death and 21,465 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 certolizumab?
9 other medicines are given the same way (subcutaneous) and in the same FDA class as certolizumab 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. The first 8 are below. 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, Psoriasis | none listed | $1,587.82 per mL 40 mg/0.4 mL | No current entry |
| Etanercept | Rheumatoid arthritis, Psoriasis | none listed | $2,084.14 per mL 25 mg/0.5 mL syringe | No current entry |
| Golimumab | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | none listed | $12,890.32 per mL 50 mg/0.5 mL pen injec | No current entry |
| Methotrexate | Rheumatoid arthritis, Psoriasis | 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 |
| Adalimumab-ryvk | Rheumatoid arthritis, Crohn's disease and ulcerative colitis, Psoriasis | none listed | $499.12 per unit 40 mg/0.4 mL autoinjector | A presentation being discontinued |
| 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 |
Every medicine labeled for the same conditions as certolizumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does certolizumab compare with medicines for the same use?
2 side-by-side pages set certolizumab beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to certolizumab
- 9 medicines for the same use
- Other TNF blockers
- the pharmacologic class, with prices and generics
- Certolizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other