Etanercept Biosimilar Drug Aliquot | Anti TNF-α | Therapeutic Fusion Protein

Aliquoted from the biosimilar drug | Now available for research use

Aliquots of the biosimilar drug Etanercept (Nepexto®) are now available as research consumables.

Etanercept drug aliquots can be used for in vitro or in vivo experiments. Several other reference drugs and biosimilars are also available.

The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed biosimilar drug.

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Nepexto® / Etanercept Biosimilar Product

Drug nameNepexto®
INNEtanercept
API typeFusion protein
Pharmacotherapeutic group
Immunosuppressants, tumour necrosis factor-alpha (TNF-α) inhibitors
ATC code
L04AB01
Target of antibody
TNF alpha
General function
Short descriptionEtanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive. Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis. In plaque psoriasis, infiltration by inflammatory cells, including T-cells, leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin. Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs). Both TNFRs exist naturally in membrane-bound and soluble forms. Soluble TNFRs are thought to regulate TNF biological activity.
Original license holder
Mylan IRE Healthcare Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland
Marketing authorisation numbers
EU/1/20/1436/001-008
Marketing authorisation holder
Mylan IRE Healthcare Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland
Name of the manufacturer of the biological active substance
Lupin Limited (Biotech Division)
Gat No. 1156, 1157, 1158, 1159 and 1160, Village Ghotawade,
Taluka Mulshi, Dist. Pune - 412 115,
Maharashtra, India
Name and address of the manufacturer(s) responsible for batch releaseMcDermott Laboratories Ltd T/A Mylan Dublin Biologics
Newenham Court
Northern Cross
Malahide Road
Dublin 17
Ireland

Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany
Max shelf life
2 years
Storage conditions
2°C – 8°C
List of excipients
Sodium citrate
Sodium dihydrogen phosphate dihydrate
Glycine
Sucrose
Sodium chloride
Water for injections

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Evidentic offers multiple batches of original drug aliquots in low binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.

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