U.S. License Holder:
Amgen, Inc.
Date of License:
September-23-2016
Last Update:
Sep-30-2025
FDA-Approved Indications
AMJEVITA (adalimumab-atto) is a tumor necrosis factor (TNF) blocker indicated for:
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 rheumatoid arthritis;
Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older;
Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis;
Reducing signs and symptoms in adult patients with active ankylosing spondylitis;
Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older;
Treatment of moderately to severely active ulcerative colitis in adult patients;
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;
Treatment of moderate to severe hidradenitis suppurativa in adult patients;
Treatment of non-infectious intermediate, posterior and panuveitis in adult patients.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Amgevita (Amgen) (November-2020)
Biosimilars Approved In The E.U.
Amgevita (Amgen) (March-2017)
Biosimilars Approved In Australia
Amgevita (Amgen) (November-2017)
Inter Partes Review Proceedings
U.S. Patent Litigations
