U.S. License Holder:
Amgen, Inc.
Date of License:
September-23-2016
Last Update:
September-23-2022
FDA-Approved Indications
AMJEVITA (adalimumab-atto) is a tumor necrosis factor (TNF) blocker indicated for treatment of:
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 active PsA;
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;
Plaque Psoriasis (Ps): The 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.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Amgevita (Amgen) (November-2020)
Biosimilars Approved In The E.U.
Amgevita (Amgen) (March-2017)
Inter Partes Review Proceedings
U.S. Patent Litigations
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