Amjevita FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 10, 2024.

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/interchangeable 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 indicated for:
  - Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
  - Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
  - Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with activePsA.
  - Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
  - Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
  - Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients.
  Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF-blockers.
  - Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemictherapy or phototherapy, and when other systemic therapies are medicallyless appropriate.
  - Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients.
  - Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
• Amjevita is approved in the following dosage forms:
  • single-dose prefilled SureClick® autoinjector:
    - 80 mg/0.8 mL (biosimilar)
    - 40 mg/0.8 mL (interchangeable)
    - 40 mg/0.4 mL (biosimilar)
  • single-dose prefilled glass syringe:
    - 80 mg/0.8 mL (biosimilar)
    - 40 mg/0.8 mL (interchangeable)
    - 40 mg/0.4 mL (biosimilar)
    - 20 mg/0.4 mL (interchangeable)
    - 20 mg/0.2 mL (biosimilar)
    - 10 mg/0.2 mL (interchangeable)
• 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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