U.S. License Holder:
Fresenius Kabi USA
Date of License:
December-13-2022
Last Update:
Sep-15-2023
FDA-Approved Indications
IDACIO (adalimumab-aacf) 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 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): 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
Idacio® (Fresenius Kabi) (October-2020)
Biosimilars Approved In The E.U.
Idacio® (Fresenius Kabi) (April-2019) Kromeya (adalimumab) (Fresenius Kabi) (April-2019)
Biosimilars Approved In Australia
Idacio® (Fresenius Kabi) (June-2020)
Inter Partes Review Proceedings
