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What is the difference between Amjevita and Humira?

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

Official Answer

by Drugs.com

Amjevita (adalimumab-atto) 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.

Amjevita (adalimumab-atto) was the first 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 Amjevita are not the same.

Like Humira, Amjevita 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, Amjevita 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 Amjevita:

Indication Humira Amjevita
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

Amjevita is not approved as an interchangeable product at the pharmacy, meaning the pharmacist needs approval from the prescribing doctor to substitute Amjevita for Humira if not specified on the prescription.

Amjevita and Humira are both administered via subcutaneous injection.

  • Amjevita is available as a prefilled syringe and SureClick® autoinjector.
  • 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. AMJEVITA Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761024s004lbl.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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