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Key takeaways
Cyltezo and Humira are prescription medications that are administered by subcutaneous injection (injection under the skin) for various inflammatory diseases, such as rheumatoid arthritis, plaque psoriasis, and Crohn’s disease.
These medications are classified as tumor necrosis factor blockers and work by blocking chemical messengers that cause inflammation.
Humira is a biologic and is known as a reference drug, or brand-name drug. Cyltezo is an interchangeable biosimilar, which is like a generic drug but for a biologic drug. Because they both contain the same ingredient and work the same way, they are very similar but have a few slight differences.
Consult your healthcare provider for more information and medical advice about your condition and treatment options.
Humira and Cyltezo are injectable prescription medications that treat various autoimmune inflammatory conditions such as rheumatoid arthritis, plaque psoriasis, and Crohn’s disease. They both contain the active ingredient adalimumab and are classified in a group of medications called tumor necrosis factor (TNF) blockers. They work by blocking the action of TNF, a cytokine (chemical messenger), which causes inflammation. Although these drugs contain the same active ingredient, there are some differences.
Cyltezo vs. Humira: Key differences
Cyltezo and Humira are both TNF blockers that contain the active ingredient adalimumab. Humira is a brand-name medication made by the pharmaceutical company AbbVie, Inc. Cyltezo is an interchangeable biosimilar (similar to a generic, but for biologic drugs like Humira) made by Boehringer Ingelheim Pharmaceuticals, Inc. The table below provides some basic information about both drugs.
Cyltezo vs. Humira: Key similarities & differences |
||
|---|---|---|
| Cyltezo | Humira | |
| Drug class | Tumor necrosis factor blocker (TNF blocker) | Tumor necrosis factor blocker (TNF blocker) |
| Brand/generic status | Interchangeable biosimilar (similar to a generic for a brand-name drug) | Brand (also known as the reference drug) |
| What is the active ingredient? | Adalimumab | Adalimumab; adalimumab-adbm |
| What form(s) does the drug come in? | Prefilled pen: 40 mg/0.8 ml
Prefilled syringe: 10 mg/0.2 ml, 20 mg/0.4 ml, 40 mg/0.8 ml |
Prefilled pen: 40 mg/0.4 ml, 40 mg/0.8 ml, 80 mg/0.8 ml
Prefilled syringe: 10 mg/0.1 ml, 20 mg/0.2 ml, 40 mg/0.4 ml, 40 mg /0.8 ml, 80 mg/0.8 ml |
| What is the standard dosage? | Varies by age and indication | Varies by age and indication |
| How long is the typical treatment? | Varies | Varies |
| Who typically uses the medication? | Adults
Pediatric patients for certain indications |
Adults
Pediatric patients for certain indications |
Cyltezo vs. Humira: Conditions treated
Cyltezo and Humira are both approved by the Food and Drug Administration (FDA) for the same uses, although the ages for use vary for some indications. These medications are typically used in combination with other medications when other treatments have not been effective on their own.
The conditions in the chart below are the approved uses for Cyltezo and Humira. Cyltezo has the same FDA-approved uses as Humira, except Cyltezo is only FDA-approved for use in adults for ulcerative colitis, hidradenitis suppurativa, and uveitis.
Compare conditions treated by Cyltezo & Humira |
||
|---|---|---|
| Condition | Cyltezo | Humira |
| Moderately to severely active rheumatoid arthritis | Yes (adults) | Yes (adults) |
| Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years and older | Yes | Yes |
| Psoriatic arthritis | Yes (adults) | Yes (adults) |
| Ankylosing spondylitis | Yes (adults) | Yes (adults) |
| Moderately to severely active Crohn’s disease (a type of inflammatory bowel disease) | Yes (adults and pediatric patients 6 years and older) | Yes (adults and pediatric patients 6 years and older) |
| Moderately to severely active ulcerative colitis (a type of inflammatory bowel disease) | Yes (approved for use in adults only) | Yes (adults and pediatric patients 5 years and older) |
| Moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy | Yes (adults) | Yes (adults) |
| Moderate to severe hidradenitis suppurativa | Yes (approved for use in adults only) | Yes (ages 12 years and older) |
| Uveitis | Yes (approved for use in adults only) | Yes (adults and pediatric patients 2 years and older) |
Is Humira better than Cyltezo?
Humira is a biologic drug and a monoclonal antibody that the FDA approved in 2002. Biologics come from natural sources like animals or humans and may be produced with biotechnology. According to the FDA, while nonbiologic drugs are manufactured with specific chemicals and have a known chemical structure, most biologics are complex mixtures and cannot be easily characterized or identified.
Because Humira is a biologic, it does not have a generic. Rather, Humira is known as a reference drug, and Cyltezo is what’s called a biosimilar drug. Humira has various adalimumab biosimilars available by prescription. Boehringer Ingelheim’s Cyltezo received FDA approval as a biosimilar in 2017 and then received approval as an interchangeable biosimilar product in 2021. It became available in the United States in July of 2023.
A biosimilar is an almost identical copy of the approved biologic (reference) drug—in this case, Humira. Because biologics are complex, biosimilars cannot be exactly the same. However, biosimilars are made of the same active ingredient, work the same way, and have the same mode of administration (such as injection) and dosing as the reference product. Before they can be approved on the market, biosimilars must go through clinical studies to ensure they are the same in terms of safety and efficacy as the reference drug.
While there are various Humira biosimilars, some, including Cyltezo, are also considered interchangeable. Not all biosimilars are interchangeable. An interchangeability designation means the biosimilar can be substituted (considered interchangeable) for the reference product. So, if a prescription is issued for Humira, the pharmacy can automatically dispense Cyltezo or another interchangeable biosimilar as allowed by individual state laws.
Cyltezo vs. Humira: Insurance coverage and cost comparison
Cyltezo and Humira are specialty drugs, which means you will get them from a specialty pharmacy. Your healthcare provider will help you with the process of getting your medication.
If you pay out-of-pocket for a one-month supply of Cyltezo (two single-dose pens), the price is about $7,581. You can access a SingleCare card or coupon to bring the price down to as low as $1,317.
If you pay out-of-pocket for a one-month supply of Humira (two single-dose syringes), the price is about $8,714. You can use a SingleCare card or coupon to pay a discounted price of $6,259.
While these drugs are often covered by insurance companies and Medicare prescription drug plans, your costs may vary. Contact your health insurance provider for the most recent pricing estimates. You can also check the manufacturer’s website for more information on ways to save.
Compare costs & coverage of Cyltezo vs. Humira |
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|---|---|---|
| Cyltezo | Humira | |
| Typically covered by insurance? | Yes | Yes |
| Typically covered by Medicare Part D? | Yes | Yes |
| Quantity | 1 box | 1 box |
| SingleCare cost (for a one-month supply) | $1,317 | $6,259 |
Humira vs. Cyltezo side effects
Because both drugs have the same active ingredient, side effects are the same. The most common side effects are upper respiratory infections, sinus infections, headache, rash, and injection site reactions.
Serious side effects may occur as well. Some examples of serious side effects include severe infections and heart, liver, and lung problems, among others.
This is not a full list of side effects. Consult your prescribing healthcare provider for more information and a full list of side effects.
Compare side effects of Cyltezo vs. Humira |
||||
|---|---|---|---|---|
| Cyltezo | Humira | |||
| Side Effect | Applicable? | Frequency | Applicable? | Frequency |
| Upper respiratory infection | Yes | 17% | Yes | 17% |
| Sinus infection | Yes | 11% | Yes | 11% |
| Flu | Yes | 7% | Yes | 7% |
| Nausea | Yes | 9% | Yes | 9% |
| Stomach pain | Yes | 7% | Yes | 7% |
| Headache | Yes | 12% | Yes | 12% |
| Rash | Yes | 12% | Yes | 12% |
| Injection site reaction | Yes | 8% | Yes | 8% |
| Urinary tract infection | Yes | 8% | Yes | 8% |
Source: DailyMed (Cyltezo), DailyMed (Humira)
Cyltezo and Humira drug interactions
Before taking Cyltezo or Humira, tell your healthcare about all the medications you take, including prescription drugs, over-the-counter medicines, vitamins, and supplements.
People who take Cyltezo or Humira should not take Kineret (anakinra), Orencia (abatacept), or Rituxan (rituximab) due to the increased risk of serious infections. Also, Cyltezo and Humira should not be combined with other TNF blockers due to the risk of interactions and infections.
While taking Cyltezo or Humira, you should not get live vaccines. Check with a healthcare provider or pharmacist before getting any vaccines.
People on drugs with a narrow therapeutic index (a small window between therapeutic and toxic doses or blood levels) will need careful monitoring and may need a dose adjustment.
This is not a full list of drug interactions. Consult your healthcare professional for medical advice on drug interactions and how they may affect you.
Compare Cyltezo vs. Humira drug interactions |
|||
|---|---|---|---|
| Drug | Drug Class | Interacts with Cyltezo? | Interacts with Humira? |
| Kineret (anakinra) | Interleukin antagonist | Yes | Yes |
| Orencia (abatacept) | Selective T cell costimulation modulator | Yes | Yes |
| Rituxan (rituximab) | Anti CD20 antibody | Yes | Yes |
| Cimzia (certolizumab pegol)
Enbrel (etanercept) Remicade (infliximab) Simponi (golimumab) |
TNF blockers | Yes | Yes |
| BCG intravesical
MMR vaccine Nasal influenza vaccine Rotavirus vaccines Varicella vaccine |
Live vaccines | Yes | Yes |
| Cyclosporine
Theophylline Warfarin |
Drugs with a narrow therapeutic index | Yes | Yes |
Cyltezo and Humira drug warnings
Cyltezo and Humira share the same drug warnings, including the following:
- Before you take Cyltezo or Humira, tell your healthcare provider about any medical conditions you have, including if you are pregnant or breastfeeding.
- Get emergency medical help if you have symptoms of an allergic reaction or skin reaction, such as hives; difficulty breathing or swallowing; swelling of the face, lips, tongue, or throat; red or purple rash; blistering, peeling, or painful skin; fever, burning eyes, or sore throat.
- Cyltezo and Humira can cause liver problems and can reactivate hepatitis B infection in people who are carriers. Notify your healthcare provider right away if you have symptoms of liver problems, such as fatigue, muscle aches, appetite loss, nausea, vomiting, stomach pain, dark urine, clay-colored stools, or yellowing of the skin or whites of the eyes.
- Be alert to symptoms of a nervous system problem, such as numbness or tingling, weakness, dizziness, or vision problems.
- This medication may affect the body’s ability to make enough blood cells that fight infection or help stop bleeding.
- Cyltezo and Humira can cause or worsen heart failure. Call your healthcare provider right away if you have symptoms such as shortness of breath, sudden weight gain, or swelling of the legs, ankles, or feet.
- Cyltezo and Humira can cause lupus-like syndrome, which has symptoms that include joint or chest pain, shortness of breath, or a rash on the cheeks or arms that worsens in the sun.
Cyltezo and Humira boxed warnings
Cyltezo and Humira have boxed warnings, the most serious type of warning required by the FDA. According to the warnings, there is an increased risk of serious infections, which can lead to hospitalization or death. These include tuberculosis as well as other types of bacterial or fungal infections. Before you start to take Cyltezo or Humira (and during treatment), your healthcare provider will test you for tuberculosis—and during treatment, you should notify your healthcare provider if you have any signs or symptoms of infection. These may include fever, chills, muscle aches, cough, skin sores, fatigue, weight loss, and painful or frequent urination. Your healthcare provider will not start treatment with Cyltezo or Humira if you have any type of active infection.
Additionally, lymphoma (a type of cancer) and other malignancies, some of which have been fatal, have occurred in children and adolescents taking adalimumab. People with rheumatoid arthritis may have a higher chance of getting lymphoma. TNF blockers also can increase the chance of certain types of skin cancer. Notify your healthcare provider right away if you have any skin changes, bumps, or sores. Tell your healthcare provider if you take Imuran (azathioprine) or Purinethol (mercaptopurine). Some patients who took a TNF blocker developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer, which generally occurs in teenage males or young men, often causes death. Most people who had this type of cancer were being treated for Crohn’s disease or ulcerative colitis and were also taking azathioprine or mercaptopurine.
Sources
- Adalimumab injection, MedlinePlus (2023)
- What are “biologics” questions and answers, Food & Drug Administration (2018)
- Cyltezo®, first and only FDA-approved interchangeable biosimilar to Humira®, now commercially available in the U.S., Boehringer Ingelheim (2023)
- Biosimilars: What you should know, Crohn’s & Colitis Foundation
- Specialty pharmacies, AbbVie Inc. (2022)
- Cyltezo, DailyMed (2023)
- Humira, DailyMed (2024)