etanercept   Click here for help

GtoPdb Ligand ID: 6789

Synonyms: Enbrel® | Rhu Tnfr:Fc | TNFR-Fc | TNR 001
Approved drug Immunopharmacology Ligand
etanercept is an approved drug (FDA (1998), EMA (2000))
Compound class: Antibody
Comment: Etanercept is a TNFα inhibitor. It is a dimeric recombinant protein fusing the TNF receptor 2 (TNFRSF1B) to the Fc region of the human IgG1 antibody. Etanercept is used as a disease-modifying anti-rheumatic drug (DMARD).

Biosimilars:
NameTrade nameCompanyClinical PhaseIndicationsReferences
etanercept-szzsErelziSandozApproved (2016 FDA, 2017 EMA)As per reference agent 
SB4; etanercept-ykroBrenzys; Benepali; Eticovo Samsung BioepisApproved in S Korea (2015), Canada (2016), Europe (EMA 2016), US (FDA 2019) and othersAs per reference agent[1]
 LifmiorPfizerApproved (2017 EMA)As per reference agent 
ENIA11; TuNEX; OpinerceptMycenax BiotechApproved (2018 Taiwan)Rheumatoid arthritisReuters news brief
YLB113NepextoMylanApproved (2020 EMA)As per reference agent 
EtaceptReumatoceptShanghai CP GoujianMarketed in Colombia as Etanar Rheumatoid arthritis 
CHS-0214 Coherus BiosciencesPh 3 (NCT02134210)Plaque psoriasis 
LBEC0101 LG Life SciencesPh 3 (NCT02357069)Rheumatoid arthritis[4-5]
IUPHAR Pharmacology Education Project (PEP) logo

View more information in the IUPHAR Pharmacology Education Project: etanercept

References
1. Emery P, Vencovský J, Sylwestrzak A, Leszczynski P, Porawska W, Baranauskaite A, Tseluyko V, Zhdan VM, Stasiuk B, Milasiene R et al.. (2017)
52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis.
Rheumatology (Oxford), 56 (12): 2093-2101. [PMID:28968793]
2. Feldman M, Taylor P, Paleolog E, Brennan FM, Maini RN. (1998)
Anti-TNF alpha therapy is useful in rheumatoid arthritis and Crohn's disease: analysis of the mechanism of action predicts utility in other diseases.
Transplant Proc, 30 (8): 4126-7. [PMID:9865320]
3. Goldenberg MM. (1999)
Etanercept, a novel drug for the treatment of patients with severe, active rheumatoid arthritis.
Clin Ther, 21 (1): 75-87; discussion 1-2. [PMID:10090426]
4. Lee H, Chung H, Lee S, Lee H, Yang SM, Yoon SH, Cho JY, Jang IJ, Yu KS. (2017)
LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects.
BioDrugs, 31 (4): 349-355. [PMID:28551775]
5. Matsuno H, Tomomitsu M, Hagino A, Shin S, Lee J, Song YW. (2018)
Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate.
Ann Rheum Dis, 77 (4): 488-494. [PMID:29259050]