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Amjevita FDA Approval History

Last updated by Judith Stewart, BPharm on May 24, 2023.

FDA Approved: Yes (First approved September 23, 2016)
Brand name: Amjevita
Generic name: adalimumab-atto
Dosage form: Injection
Previous Name: ABP 501
Company: Amgen Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa

Amjevita (adalimumab-atto) an anti-TNF-α monoclonal antibody biosimilar to Humira indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

  • Amjevita is a biosimilar to Humira and does not have an interchangeability designation.
  • Amjevita is a citrate-free formulation supplied as follows:
    • Single-dose prefilled SureClick® autoinjector:40 mg/0.8 mL
    • Single-dose prefilled glass syringe: 10 mg/0.2mL, 20 mg/0.4 mL, 40 mg/0.8 mL
  • Amjevita is administered via subcutaneous injection.
  • The FDA approval of Amjevita was based on analytical, nonclinical, pharmacokinetic and clinical data supporting biosimilarity to the reference product Humira. Safety and immunogenicity were also comparable.
  • Amjevita comes with a Boxed Warning alerting health care professionals and patients of the increased risk of serious infections and malignancies.
  • The most common reported side effects include infections (including upper respiratory, sinusitis), injection site reactions, headache, and rash.

Development timeline for Amjevita

Jan 31, 2023Amjevita™ (adalimumab-atto), First Biosimilar To Humira®, Now Available In The United States
Sep 23, 2016Approval FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira
Jul 12, 2016Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab
Jun 13, 2016Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab
Jan 25, 2016FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501
Nov 25, 2015Amgen's First Biosimilar Biologics License Application for ABP 501 Submitted to FDA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.