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Discover how CYLTEZO can help you

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While insurance will ultimately decide which medicine you patient receives,

CYLTEZO and Adalimumab-adbm are the exact same medicine

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CYLTEZO received FDA approval as a biosimilar in 2017, and then received approval as an Interchangeable in 2021.

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No dosage adjustments are needed when switching from a stable dose of Humira® to CYLTEZO. Current adalimumab patients do not need to repeat their loading dose...

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Study Design: VOLTAIRE-CD was a multicenter, double-blind, parallel-group, active-comparator trial of patients 18-80 years of age with moderately to severely active Crohn’s disease. Patients were ...

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Study Design: VOLTAIRE-RA was a randomized, double-blind, parallel-arm, 58-week equivalence trial of CYLTEZO and USA-sourced Humira in patients with moderate-to-severe rheumatoid arthritis ...

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Study Design: VOLTAIRE-PSO was a randomized, double-blind, parallel-arm, multiple-dose, active comparator trial for 24 weeks (with an additional 10 weeks for a safety follow-up) in adults 18 ...

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Frequently Asked Questions

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CYLTEZO (adalimumab-adbm) is an FDA-approved biosimilar to Humira (adalimumab), developed and manufactured by Boehringer Ingelheim.1

According to the FDA, a biosimilar is a biological product that has been proven to be highly similar to a reference product notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety, purity, and potency.3

The FDA first approved CYLTEZO as an interchangeable biosimilar (50 mg/mL) to Humira on October 15, 2021. CYLTEZO (100 mg/mL) was approved as an interchangeable biosimilar to Humira on May 20, 2025. For more information on interchangeability for CYLTEZO refer to the FDA’s resource on biosimilars and interchangeability, the Purple Book: https://purplebooksearch.fda.gov/.

CYLTEZO and Adalimumab-adbm are indicated for1,2:

  • Rheumatoid Arthritis (RA) – Moderate to severe RA in adults
  • Psoriatic arthritis (PsA)
  • Ankylosing spondylitis (AS)
  • Crohn’s disease (CD) – Moderate to severe CD in adults and pediatric patients ≥6 years
  • Ulcerative colitis (UC) – Moderate to severe UC in adults
  • Plaque psoriasis (PsO) – Moderate to severe chronic PsO in adults
  • Hidradenitis Suppurativa (HS disease) – Moderate to severe HS in patients 12 years of age and older
  • Juvenile idiopathic arthritis (JIA) – Moderate to severe polyarticular JIA in patients ≥2 years
  • Uveitis – Non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients ≥2 years

These indications allow for the use of CYLTEZO in clinical practice across a spectrum of autoimmune conditions. For full prescribing information and a complete list of indications, Healthcare Professionals are encouraged to refer to CYLTEZO full Prescribing Information.1 

References:

  1. CYLTEZO [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; October 2025. https://pro.boehringer-ingelheim.com/us/products/Cyltezo®/bipdf/prescribing-information

  2. Adalimumab-adbm [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; October 2025. https://pro.boehringer-ingelheim.com/us/products/cyltezo/bipdf/adalimumab-adbm-us-pi

  3. USFDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry. April 2015. Accessed May 27th 2025. https://www.fda.gov/media/82647/download

Interchangeability goes beyond biosimilarity. While all interchangeable biologics are biosimilars, not all biosimilars are interchangeable. For a biosimilar to receive this designation, the FDA may require additional evidence from switching studies that show patients can alternate between the reference product and the biosimilar without any loss of efficacy, increased safety concerns, or heightened immunogenicity risk.1,2

This interchangeability designation by the U.S. Food and Drug Administration (FDA) means that pharmacists may substitute certain biosimilars (such as CYLTEZO) for the reference product (like Humira) without prescriber intervention, depending on individual state laws.1,3 This supports expanded access to biologic therapy and may help reduce treatment costs for patients and healthcare systems alike.

References:

  1. U.S. Food and Drug Administration. 9 Things to Know About Biosimilars and Interchangeable Biosimilars. Updated June 2024. Accessed April 2025. https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars

  2. Cohen HP, Blauvelt A, Rifkin RM, et al. Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes. Drugs. 2018;78(4):463-478. doi:10.1007/s40265-018-0881-y

  3. CYLTEZO [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; October 2025. https://pro.boehringer-ingelheim.com/us/products/Cyltezo®/bipdf/prescribing-information

Yes, CYLTEZO is interchangeable with HUMIRA.1-3

The FDA granted low concentration CYLTEZO (50 mg/ml) its interchangeable status, on October 15th 2021, based on results from the VOLTAIRE-X study.1 Data showed that switching several times between CYLTEZO and HUMIRA resulted in no meaningful clinical differences for pharmacokinetics, efficacy, immunogenicity, and safety.1,2

The FDA further granted interchangeability status to high concentration CYLTEZO (100 mg/ml), on May 20th 2025. This FDA approval was based, in part, on data from clinical trial VOLTAIRE-HCLF, a Phase I clinical trial comparing the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm.3

What this means for your clinical practice:

Prescribers can confidently consider Cyltezo® as a safe and effective substitute for Humira®, supported by robust data from the VOLTAIRE-X trial and the FDA’s interchangeability standards.2,4

Pharmacist-level substitution may occur where state laws allow, potentially streamlining treatment pathways and reducing delays in access to therapy.4,5

The interchangeability designation may also reduce administrative burden by limiting the need for prior authorizations or step therapy adjustments and can facilitate broader patient access to adalimumab treatment, especially in chronic inflammatory conditions.5,6

References:

  1. Boehringer Ingelheim. Press release: MPR-US-101912. US FDA Approves CYLTEZO (adalimumab-adbm) as First Interchangeable Biosimilar with Humira. Oct 15, 2021. Accessed May 23, 2025. https://www.boehringer-ingelheim.com/us/media/press-releases/cyltezo-adalimumab-adbm-first-interchangeable-biosimilar-bi-us

  2. Menter A et al. Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial. Am J Clin Dermatol. 2022 Aug 7;23(5):719–728. doi: 10.1007/s40257-022-00708-w

  3. Boehringer Ingelheim. Press release: MPR-US-103133 (5/24). US FDA approves Boehringer Ingelheim’s high-concentration, citrate-free formulation of CYLTEZO (adalimumab-adbm) injection. May 1st, 2024. Accessed May 23rd 2025. https://www.boehringer-ingelheim.com/us/fda-approves-additional-formulation-biosimilar

  4. U.S. Food and Drug Administration. 9 Things to Know About Biosimilars and Interchangeable Biosimilars. Updated June 2024. Accessed April 2025. https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars

  5. Blackstone EA, Fuhr JP Jr. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469-478. 

  6. Mulcahy AW, Hlavka JP, Case SR. Biosimilar Cost Savings in the United States: Initial Experience and Future Potential. RAND Corporation; 2017. https://www.rand.org/pubs/perspectives/PE264.html

When selecting an adalimumab biosimilar, Healthcare Professionals should evaluate:

  • FDA-approved interchangeability status

    The interchangeability designation supports that switching between a biosimilar and the reference will not result in clinically meaningful differences in efficacy, safety, or immunogenicity. This can streamline treatment pathways, especially for patients requiring long-term biologic therapy.1

  • Indication match with patient’s diagnosis

    When selecting a biosimilar, Healthcare Professionals should ensure that the biosimilar’s approved indications align with the patient’s specific diagnosis. This ensures that the treatment is appropriate and supported by clinical evidence for the intended condition.2

  • Real-world data on switching and patient satisfaction
    Real-world evidence and clinical trials play an important role in understanding the long-term safety and effectiveness of biosimilars. Additionally, real-world data on patient satisfaction, including ease of switching and the experience of lower treatment costs, can further support decision-making. Healthcare Professionals should also consider the patient’s preference for treatment options, including the potential for greater adherence or satisfaction with a more affordable therapy.1

  • Patient support programs

    Choosing a biosimilar with strong manufacturer support programs (Like financial assistance, educational resources, nurse support etc) can be crucial in improving treatment outcomes and patient adherence. These programs can reduce the administrative burden for both patients and Healthcare Professionals and improve patient outcomes by enhancing access to therapy and encouraging adherence.3
     

References:

  1. Mayden KD et al. Biosimilars in the United States: Considerations for Oncology Advanced practitioners. J Adv Pract Oncol. 2015 Mar 1;6(2):108–116.

  2. Mysler E, et al. Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience? Drugs. 2021;81(16):1859-1879. doi: 10.1007/s40265-021-01610-1

  3. Småstuen CM, et al. OP0070-HPR. Is patients’ satisfaction with being switched to a biosimilar medication associated with their level of health literacy? Results from a Norwegian user survey. Ann Rheum Dis. 2018;77(suppl 2):86.

Biosimilars such as CYLTEZO (adalimumab-adbm) provide several advantages for healthcare providers and patients, particularly in the management of chronic immune-mediated conditions:

  • Comparable clinical performance to the reference product

    CYLTEZO has demonstrated no clinically meaningful differences in efficacy, safety, purity, and immunogenicity compared to Humira, as required by the FDA’s rigorous biosimilar approval pathway.1,2
  • Potential cost savings for the healthcare system and patients
  • Improved access to biologic therapy
    Lower costs and increased market availability of biosimilars can expand access to advanced biologic treatments for patients who may have previously faced affordability barriers—especially critical in chronic inflammatory diseases such as Rheumatoid Arthritis, Hidradenitis Suppurativa (HS disease), and Crohn’s disease.2,4

These benefits align with biosimilarity standards established by both the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO), and are increasingly supported by real-world evidence and post-marketing surveillance data from global clinical use.

References:

  1. U.S. Food and Drug Administration. 9 Things to Know About Biosimilars and Interchangeable Biosimilars. Updated June 2024. Accessed April 2025. https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars

  2. CYLTEZO [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; October 2025. https://pro.boehringer-ingelheim.com/us/products/cyltezo/bipdf/prescribing-information

  3. Blackstone EA, Fuhr JP Jr. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469-478.

  4. IGBA. Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline. 2022. https://www.igbamedicines.org/doc/Embracing-Science-with-Confidence-9-11-2022.pdf

CYLTEZO (adalimumab-adbm) is not a generic, but an FDA-approved biosimilar and interchangeable biologic to Humira (adalimumab). While generics are exact chemical copies of small-molecule drugs, biosimilars are large, complex molecules derived from living cells, and are demonstrated to be highly similar to the reference biologic with no clinically meaningful differences in terms of safety, purity, or efficacy.1

CYLTEZO has been evaluated to confirm structural and functional similarity to Humira, including through analytical, nonclinical, and clinical comparisons, as per FDA biosimilar standards.1 It is also the first adalimumab biosimilar approved as interchangeable with Humira*.

CYLTEZO offers Healthcare Professionals a clinically equivalent and potentially cost-effective alternative to Humira for managing approved indications including conditions such as Hidradenitis Suppurativa (HS disease) and Rheumatoid Arthritis (RA).1,3

References:

  1. CYLTEZO [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; October 2025. https://pro.boehringer-ingelheim.com/us/products/cyltezo/bipdf/prescribing-information

  2. FDA Approves CYLTEZO, the First Interchangeable Biosimilar to Humira. Oct 18, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-Cyltezo®-first-interchangeable-biosimilar-Humira®

  3. Mulcahy AW, Hlavka JP, Case SR. Biosimilar Cost Savings in the United States: Initial Experience and Future Potential. RAND Corporation; 2017. https://www.rand.org/pubs/perspectives/PE264.html

*The FDA first approved CYLTEZO as an interchangeable biosimilar (50 mg/mL) to Humira on October 15, 2021. CYLTEZO (100 mg/mL) was approved as an interchangeable biosimilar to Humira on May 20, 2025. For more information on interchangeability for CYLTEZO refer to the FDA’s resource on biosimilars and interchangeability, the Purple Book: https://purplebooksearch.fda.gov/.

INDICATIONS FOR CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use

Rheumatoid Arthritis: CYLTEZO is 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. CYLTEZO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis: CYLTEZO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. CYLTEZO can be used alone or in combination with methotrexate.

Psoriatic Arthritis: CYLTEZO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. CYLTEZO can be used alone or in combination with non-biologic DMARDs.

Ankylosing Spondylitis: CYLTEZO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn’s Disease: CYLTEZO is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis: CYLTEZO is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
Limitations of Use:
The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.

Plaque Psoriasis: CYLTEZO is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. CYLTEZO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa: CYLTEZO is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

Uveitis: CYLTEZO is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult and pediatric patients 2 years of age and older.

IMPORTANT SAFETY INFORMATION FOR CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use

This important information also applies to Adalimumab-adbm injection for subcutaneous use.

WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS

Patients treated with adalimumab products, including CYLTEZO, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue CYLTEZO if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CYLTEZO use and during therapy. Initiate treatment for latent TB prior to CYLTEZO 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. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with CYLTEZO prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CYLTEZO, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start CYLTEZO during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of CYLTEZO with other biologic DMARDS (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

  • Consider the risks and benefits of TNF-blocker treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials of some TNF-blockers, including adalimumab products, more cases of malignancies were observed among TNF-blocker-treated patients compared to control patients.
  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with CYLTEZO.
  • In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

Hypersensitivity Reactions

  • Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If a serious allergic reaction occurs, stop CYLTEZO and institute appropriate therapy.

Hepatitis B Virus Reactivation

  • Use of TNF blockers, including CYLTEZO, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in patients who are carriers of HBV and monitor them during and after CYLTEZO treatment. Discontinue CYLTEZO and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CYLTEZO after HBV treatment.

Neurologic Reactions

  • TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering CYLTEZO for patients with these disorders; discontinuation of CYLTEZO should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders.

Hematological Reactions

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping CYLTEZO if significant hematologic abnormalities occur.

Congestive Heart Failure

  • Worsening or new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab. Exercise caution when using CYLTEZO in patients who have heart failure and monitor them carefully.

Autoimmunity

  • Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome or autoimmune hepatitis. Discontinue treatment if symptoms of a lupus-like syndrome or autoimmune hepatitis develop.

Immunizations

  • Patients on CYLTEZO should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating CYLTEZO therapy. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

  • The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

CL-CTZ-100026 OCT 2025

Please see Prescribing Information for Cyltezo, including Boxed Warning, and Medication Guide. Please see Prescribing Information for Adalimumab-adbm, including Boxed Warning, and Medication Guide.