What is the difference between Amjevita and Humira?
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)
- Yusimry (adalimumab-aqvh)
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:
|Rheumatoid Arthritis (RA)||adults||adults|
|Juvenile Idiopathic Arthritis (JIA)||
patients 2 years of age
|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.
- 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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