etanercept

Home
Ligands
etanercept

GtoPdb Ligand ID: 6789

Synonyms: Enbrel® | Rhu Tnfr:Fc | TNFR-Fc | TNR 001

etanercept is an approved drug (FDA (1998), EMA (2000))

Compound class: Peptide or derivative

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:

Name	Trade name	Company	Clinical Phase	Indications	References
etanercept-szzs	Erelzi	Sandoz	Approved (2016 FDA, 2017 EMA)	As per reference agent
SB4; etanercept-ykro	Brenzys; Benepali; Eticovo	Samsung Bioepis	Approved in S Korea (2015), Canada (2016), Europe (EMA 2016), US (FDA 2019) and others	As per reference agent	[1]
	Lifmior	Pfizer	Approved (2017 EMA)	As per reference agent
ENIA11;	TuNEX; Opinercept	Mycenax Biotech	Approved (2018 Taiwan)	Rheumatoid arthritis	Reuters news brief
YLB113	Nepexto	Mylan	Approved (2020 EMA)	As per reference agent
Etacept	Reumatocept	Shanghai CP Goujian	Marketed in Colombia as Etanar	Rheumatoid arthritis
CHS-0214		Coherus Biosciences	Ph 3 (NCT02134210)	Plaque psoriasis
LBEC0101		LG Life Sciences	Ph 3 (NCT02357069)	Rheumatoid arthritis	[4-5]

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]

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]