Biosimilar to Humira® | Adalimumab-adbm and CYLTEZO® (adalimumab-adbm) injection

Adalimumab-adbm is made in the US

Adalimumab-adbm is as safe and effective as Humira® for your patients

Adalimumab-adbm, the first ever interchangeable* biosimilar to Humira®, is the exact same medicine as CYLTEZO®

Adalimumab-adbm: Made in the US and interchangeable* with Humira

Adalimumab-adbm is the first ever interchangeable biosimilar to Humira.* Adalimumab-adbm and CYLTEZO® are the exact same medicine. They are both manufactured in the US by Boehringer Ingelheim, one of the largest producers of biologic medicines in the world.

Learn more about the CYLTEZO Switching Study

Frequently asked questions

About Adalimumab-adbm and CYLTEZO

CYLTEZO or Adalimumab-adbm is an FDA-approved biosimilar to Humira (adalimumab), developed and manufactured by Boehringer Ingelheim.1,2,*

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

Adalimumab-adbm is indicated for: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
• Plaque psoriasis (PsO) – Moderate to severe chronic PsO in adults
• Hidradenitis suppurativa (HS disease) – Moderate to severe HS in adults and adolescents 12 years of age and older
• Juvenile idiopathic arthritis (JIA) – Moderate to severe polyarticular JIA in patients ≥2 years
• Uveitis – Noninfectious intermediate, posterior, and panuveitis in adults and pediatric patients ≥2 years

These indications allow for the use of Adalimumab-adbm 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 Adalimumab-adbm full Prescribing Information and CYLTEZO full Prescribing Information.1,2

What is the difference between Adalimumab-adbm and CYLTEZO?

Boehringer Ingelheim offers insurers Adalimumab-adbm, which is 81% off Humira wholesale acquisition cost (WAC), and CYLTEZO, which is 5% off Humira WAC. While insurance will ultimately determine which product your patient receives, Adalimumab-adbm and CYLTEZO are the exact same medicine.

Is Adalimumab-adbm a generic version of Humira used to treat diseases like hidradenitis suppurativa (HS) or rheumatoid arthritis (RA)?

Adalimumab-abdm (or CYLTEZO) is not a generic; it is an FDA-approved biosimilar and interchangeable* biologic to Humira (adalimumab).1-3 Generics are exact chemical copies of small-molecule drugs. By contrast, 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.2

Adalimumab-adbm has been evaluated to confirm structural and functional similarity to Humira, including through analytical, nonclinical, and clinical comparisons, as per FDA biosimilar standards.2-6 It is also the first adalimumab biosimilar approved as interchangeable with Humira.6,7

Adalimumab-adbm offers healthcare providers a clinically equivalent and potentially cost-effective alternative to Humira for managing approved indications, including conditions such as HS or RA.8

About Biologics and Biosimilars

What does interchangeability mean?

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.1-3

This interchangeability designation by the FDA means that pharmacists may substitute certain biosimilars (such as Adalimumab-adbm) 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.

Is Adalimumab-adbm interchangeable with Humira?

Yes, Adalimumab-adbm is interchangeable* with Humira,1-3 and Adalimumab-adbm and CYLTEZO are the exact same medicine.

The FDA granted low-concentration CYLTEZO (50 mg/mL) its interchangeable status on October 15, 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 20, 2025. This FDA approval was based, in part, on data from the 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*: You can confidently consider Adalimumab-adbm 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 Adalimumab-adbm and CYLTEZO are the exact same medicine.

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

Prescribing Adalimumab-adbm

What should I consider when selecting a biosimilar like Adalimumab-adbm over other adalimumab biosimilars?

When selecting an adalimumab biosimilar, you 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

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. 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 (e.g., financial assistance, educational resources, nurse support) can be crucial in improving treatment outcomes and patient adherence. These programs can reduce the administrative burden for both you and your patients and improve patient outcomes by enhancing access to therapy and encouraging adherence.3

What are the key benefits of prescribing a biosimilar like Adalimumab-adbm over the originator biologic?

Biosimilars such as Adalimumab-adbm provide several advantages for you and your patients, particularly in the management of chronic immune-mediated conditions:

• Comparable clinical performance to the reference product

Adalimumab-adbm 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 RA, HS, and Crohn’s disease.1,3

These benefits align with biosimilarity standards established by both the FDA and the World Health Organization (WHO) and are increasingly supported by real-world evidence and postmarketing surveillance data from global clinical use.

Important Safety Information for Adalimumab-adbm (adalimumab-adbm) injection, for subcutaneous use

WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS

Patients treated with adalimumab products, including Adalimumab-adbm, 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 Adalimumab-adbm 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 Adalimumab-adbm use and during therapy. Initiate treatment for latent TB prior to Adalimumab-adbm use.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis...

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