U.S. License Holder:
Fresenius Kabi USA
Date of License:
December-13-2022
Last Update:
Nov-15-2024
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;
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.
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
