What is the difference between Cyltezo and Humira?
Cyltezo (adalimumab-adbm) is an Interchangeable biosimilar to Humira (adalimumab), an anti-TNF-α monoclonal antibody used for the treatment of multiple conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
A biosimilar is a product that is highly similar to an FDA-approved biologic, known as the reference product. Biosimilars have no clinically meaningful differences in safety, purity or potency compared to the reference product.
To achieve the interchangeable designation, the FDA requires an Interchangeability study, which is an additional clinical study of multiple substitutions in patients to show how patients do when they are switched back and forth multiple times from a reference product to the Interchangeable biosimilar.
A biosimilar with an Interchangeable designation can be auto-substituted by a pharmacist for the reference product, with individual state laws controlling how and whether physicians will be notified.
Cyltezo (adalimumab-adbm) was the second Humira (adalimumab) biosimilar approved by the FDA.
FDA approved biosimilars to Humira include:
- Amjevita (adalimumab-atto)
- Cyltezo (adalimumab-adbm)
- Hyrimoz (adalimumab-adaz)
- Hadlima (adalimumab-bwwd)
- Abrilada (adalimumab-afzb)
- Hulio (adalimumab-fkjp)
- Yusimry (adalimumab-aqvh)
- Yuflyma (adalimumab-aaty)
The approved indications for Humira and Cyltezo are the same, with variations in population groups.
Like Humira, Cyltezo is used for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
The following table compares the approved indications for Humira and Cyltezo:
| Indication | Humira | Cyltezo |
|---|---|---|
| Rheumatoid Arthritis (RA) | adults | adults |
| Juvenile Idiopathic Arthritis (JIA) |
patients 2 years of age and older |
patients 2 years of age and older |
| Psoriatic Arthritis (PsA) | adults | adults |
| Ankylosing Spondylitis (AS) | adults | adults |
| Crohn’s Disease (CD) | patients 6 years of age and older | patients 6 years of age and older |
| Ulcerative Colitis (UC) | patients 5 years of age and older | adults |
| Plaque Psoriasis (Ps) | adults | adults |
| Hidradenitis Suppurativa (HS) | patients 12 years of age and older | adults |
| Uveitis (UV) | patients 2 years of age and older | adults |
Cyltezo is an interchangeable biosimilar to Humira. A biosimilar with an Interchangeable designation can be auto-substituted by a pharmacist for the reference product.
Cyltezo and Humira are both administered via subcutaneous injection.
- Cyltezo is available as a single-dose prefilled syringe and a single dose prefilled pen
- Humira is available as a single-dose prefilled pen, prefilled syringe, and single-dose vial.
See What Are Biosimilars? Top Facts You May Not Know
Related Questions
References
- U.S. Food and Drug Administration. HUMIRA Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf [Accessed September 20, 2023]
- U.S. Food and Drug Administration. CYLTEZO Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s018lbl.pdf [Accessed September 20, 2023]
- U.S. Food and Drug Administration. What is a Biosimilar? Available at https://www.fda.gov/media/108905/download [Accessed March 2, 2021]
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