U.S. License Holder:
Samsung Bioepis Co. Ltd.
Date of License:
April-25-2019
Last Update:
Sep-30-2024
FDA-Approved Indications
ETICOVO (etanercept-ykro) is a tumor necrosis factor (TNF) blocker indicated for the treatment of Adult patients with:
Rheumatoid Arthritis (RA);
Psoriatic Arthritis (PsA);
Ankylosing Spondylitis (AS);
Plaque Psoriasis (PsO);
Pediatric patients with:
Polyarticular Juvenile Idiopathic Arthritis (JIA) 2 years of age or older;
Plaque Psoriasis (PsO) 4 years of age or older.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Brenzys (Samsung Bioepis / Merck Canada) (August-2016)
Biosimilars Approved In The E.U.
Benepali (Samsung Bioepis / Biogen) (January-2016)
Biosimilars Approved In Australia
Brenzys (Samsung Bioepis) (July-2016)
Biosimilars Approved In South Korea
Etoloce (Samsung Bioepis) (September-2015)