U.S. License Holder:
Sandoz Inc.
Date of License:
October-30-2018; sBLA for high concentration pending
Last Update:
January-23-2023
FDA-Approved Indications
HYRIMOZ (adalimumab-adaz) is a tumor necrosis factor (TNF)-blocker 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 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 adult 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): 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
Hyrimoz® (Sandoz Canada) (November-2020)
Biosimilars Approved In The E.U.
Hyrimoz® (Sandoz) (July-2018)
Biosimilars Approved In Australia
Hyrimoz® (Sandoz) (May-2019)