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What is the difference between Cyltezo and Humira?

Medically reviewed by Judith Stewart, BPharm. Last updated on March 2, 2021.

Official Answer

by Drugs.com

Cyltezo (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)

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 4 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 adults
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 not an interchangeable product with Humira; the physician must write a prescription specifically for Cyltezo.

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.

See What Are Biosimilars? Top Facts You May Not Know

References
  • U.S. Food and Drug Administration. HUMIRA Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf [Accessed March 2, 2021]
  • U.S. Food and Drug Administration. CYLTEZO Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761058s003lbl.pdf [Accessed March 2, 2021]
  • 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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