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 (Erelzi®) 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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Erelzi® / Etanercept Biosimilar Product

Drug nameErelzi®
INNEtanercept
API typeEtanercept 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.
Pharmacotherapeutic group
Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors
ATC code
L04AB01
Target of antibody
TNF-receptor p75 Fc
General functionThe active substance in Erelzi, etanercept, is a protein that has been designed to block the activity of a substance called tumour necrosis factor alpha (TNF). This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Erelzi is used to treat. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Short descriptionEtanercept in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF. 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.
TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs. Dimeric soluble receptors, such as etanercept, possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors. In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life.
Original license holder
Sandoz GmbH
Biochemiestr. 10
A-6250 Kundl
Austria
Marketing authorisation numbers
EU/1/17/1195/001-014
Marketing authorisation holder
Sandoz GmbH
Biochemiestr. 10
A-6250 Kundl
Austria
Name of the manufacturer of the biological active substance
Sandoz GmbH Schaftenau
Biochemiestrasse 10
A-6336 Langkampfen
AUSTRIA

Novartis Singapore Pharmaceutical
Manufacturing Pte. Ltd.
BioProduction Operations
8 Tuas Bay Lane
Singapore 636986
Name and address of the manufacturer(s) responsible for batch releaseSandoz GmbH Schaftenau
Biochemiestrasse 10
A-6336 Langkampfen
AUSTRIA
Max shelf life
36 months
Storage conditions
2°C – 8°C
List of excipients
Citric acid anhydrous
Sodium citrate dihydrate
Sodium chloride
Sucrose
L-Lysine hydrochloride
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
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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