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

Aliquoted from the original biosimilar drug | Now available for research use

Aliquots of the biosimilar drug Etanercept are now available as research consumables.

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

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

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Benepali® / Etanercept Biosimilar Product

Drug nameBenepali®
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 function
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
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands
Marketing authorisation numbers
EU/1/15/1074/001
Marketing authorisation holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands
Name of the manufacturer of the biological active substance
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1
Hillerød, 3400
Denmark

Samsung BioLogics Co., Ltd.
300, Songdo bio-daero
Yeonsu-gu, Incheon City, 21987
Republic of Korea
Name and address of the manufacturer(s) responsible for batch releaseFUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1
Hillerød, 3400
Denmark

Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands
Max shelf life
3 years
Storage conditions
2°C – 8°C
List of excipients
Sucrose
Sodium chloride
Sodium dihydrogen phosphate monohydrate
Disodium hydrogen phosphate heptahydrate
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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