What is the difference between Cyltezo and Humira?
Cyltezo (adalimumab-adbm) is an FDA-approved interchangeable biosimilar to Humira (adalimumab). Both medications are anti-TNF-α monoclonal antibodys 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.
What Is a Biosimilar?
A biosimilar is a product that is highly similar to an FDA-approved biologic (reference product) with no clinically meaningful differences in safety, purity, or potency.
- Interchangeable biosimilars undergo additional FDA studies to confirm that switching between the biosimilar and reference product does not affect safety or effectiveness.
- Pharmacists may substitute Cyltezo for Humira without prescriber approval, subject to state laws.
FDA-Approved Humira Biosimilars
Cyltezo (adalimumab-adbm) was the second Humira (adalimumab) biosimilar approved by the FDA. Other biosimilars to Humira include:
- Amjevita (adalimumab-atto)
- Hyrimoz (adalimumab-adaz)
- Hadlima (adalimumab-bwwd)
- Abrilada (adalimumab-afzb)
- Hulio (adalimumab-fkjp)
- Idacio (adalimumab-aacf)
- Simlandi (adalimumab-ryvk)
- Yusimry (adalimumab-aqvh)
- Yuflyma (adalimumab-aaty)
Is Cyltezo citrate-free?
Yes, Cyltezo is citrate-free. Most newer Humira biosimilars omit citrate, reducing injection-site pain.
Approved Uses: Cyltezo vs. Humira
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.
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How Are Cyltezo and Humira Administered?
Cyltezo and Humira are both administered via subcutaneous injection, meaning they are injected under the skin.
- 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.
Key Takeaways
- Cyltezo is an interchangeable biosimilar to Humira, meaning pharmacists can substitute it without prescriber approval in some states.
- Both medications are used to treat similar conditions, with slight differences in age group approvals.
- Both are given as subcutaneous injections, but Humira has more formulation options.
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]
Read next
Does Humira cause weight gain or weight loss?
The manufacturer of Humira does not list weight gain or weight loss as a possible direct side effect associated Humira. However, other conditions, symptoms, or medications may affect your weight while you are using this medication. Clinical studies have also shown weight gain with Humira. Continue reading
How long does it take for Humira to work?
Most patients will start to feel relief from their symptoms within 2 to 12 weeks. Your results will vary based on your condition being treated and other factors, such as tolerability to treatment and other medications you may be using. Continue reading
How long can Humira be out of the fridge?
If you are traveling or not able to keep your Humira in the refrigerator, you can store it at room temperature up to a maximum of 77 degrees F (25 degrees C) for a period of up to 14 days. Once your Humira Pen or prefilled syringe has reached room temperature, it must be used within 14 days even if it is put back in the refrigerator. Continue reading
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