What is the difference between Cyltezo and Humira?
Official answer
by Drugs.comCyltezo (adalimumab-adbm) is a 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, and plaque psoriasis.
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.
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)
The approved indications for Humira and Cyltezo are not the same.
Like Humira, Cyltezo is used for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
Unlike Humira, Cyltezo is not approved for the treatment of hidradenitis suppurativa or uveitis.
Indications may also differ across population groups.
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 | |
| Uveitis (UV) | patients 2 years of age and older |
Cyltezo is an interchangeable product with 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.
- Humira is available as a single-dose prefilled pen, prefilled syringe, and single-dose vial.
References
- U.S. Food and Drug Administration. HUMIRA Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf [Accessed May 12, 2022]
- U.S. Food and Drug Administration. CYLTEZO Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761058s008lbl.pdf [Accessed May 12, 2022]
- 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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