U.S. License Holder:
Immunex
Date of License:
November-02-1998
Last Update:
May-23-2023
FDA-Approved Indications
ENBREL (etanercept) is a tumor necrosis factor (TNF) blocker indicated for the treatment of:
Rheumatoid Arthritis (RA);
Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years or older;
Psoriatic Arthritis (PsA);
Ankylosing Spondylitis (AS);
Plaque Psoriasis (PsO) in patients 4 years or older.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Approved by FDA
Erelzi®: Sandoz (August-2016) Eticovo®: Samsung Bioepis (April-2019)
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Brenzys (Samsung Bioepis / Merck Canada) (August-2016) Erelzi (Sandoz) (April-2017) Rymti® (Lupin) (September-2022)
Biosimilars Approved In The E.U.
Benepali (Samsung Bioepis / Biogen) (January-2016) Erelzi (Sandoz) (June-2017) Nepexto (Mylan / Lupin) (June-2020)
Biosimilars Approved In Australia
Brenzys (Samsung Bioepis) (July-2016) Erelzi (Sandoz) (November-2017)
Biosimilars Approved In Japan
LBEC0101 (LG Chem Ltd.) (January-2018)
Biosimilars Approved In South Korea
Davictrel (HD203) (Hanwha Chemical / Merck) (November-2014) Eucept (LG Chem) (March-2018) SB4 (Brenzys/Benepali) (Samsung Bioepis) (September-2015) YLB133 (Lupin / YL Biologics) (March-2019)