Amjevita FDA Approval History
Last updated by Judith Stewart, BPharm on April 29, 2025.
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 systemic therapy or phototherapy, and when other systemic therapies are medically less 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:
Product Presentation Strength Biosimilar / Interchangeable Pre-Filled Syringe 10 mg / 0.2 mL Interchangeable Pre-Filled Syringe 20 mg / 0.2 mL Interchangeable Pre-Filled Syringe 20 mg / 0.4 mL Interchangeable Pre-Filled Syringe 40 mg / 0.4 mL Biosimilar Pre-Filled Syringe 40 mg / 0.8 mL Interchangeable Pre-Filled Syringe 80 mg / 0.8 mL Interchangeable Autoinjector 40 mg / 0.4 mL Biosimilar Autoinjector 40 mg / 0.8 mL Interchangeable Autoinjector 80 mg / 0.8 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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