Amjevita FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 20, 2023.
FDA Approved: Yes (First approved September 23, 2016)
Brand name: Amjevita
Generic name: adalimumab-atto
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis
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, hidradenitis suppurativa, and uveitis.
- 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: 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL
- Single-dose prefilled glass syringe: 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.4 mL, 20 mg/0.2 mL, 10 mg/0.2 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
Further information
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