Golimumab

Therapeutic Golimumab antibody from the original Simponi® commercial drug.

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Product
Batch

Antigen
Molecular Class
Drug Brand
Product Concentration
CoA
Quantity per vial
Storage Temperature
Expiry Date
Price
TNF alpha
Monoclonal Antibody
Simponi®
100 mg/mL
4 mg
-80°C
06/2018
696,00 
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Max: 10
Min: 1
Step: 1
TNF alpha
Monoclonal Antibody
Simponi®
100 mg/mL
4 mg
-80°C
03/2019
696,00 
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Max: 10
Min: 1
Step: 1
TNF alpha
Monoclonal Antibody
Simponi®
100 mg/mL
4 mg
-80°C
04/2023
835,00 
view product
Max: 5
Min: 1
Step: 1
TNF alpha
Monoclonal Antibody
Simponi®
100 mg/mL
4 mg
-80°C
06/2023
696,00 
view product
Max: 10
Min: 1
Step: 1

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Simponi® / Golimumab Reference Product

Drug nameSimponi®
INNGolimumab
API typeHuman IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology.
Pharmacotherapeutic group
Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors
ATC code
L04AB06
Target of antibody
TNF-α; Synonyms: DIF, TNF-alpha, TNFA, TNFSF2, RATTNF, Tnfa, tnf, TNF-a, TNFalpha, Tnfsf1a, TNFa, cTNF, Tnf-alpha, tnfa-like, TNF-ALPHA, dif, tnfa, xtnf, tnfsf2, tnf-alpha, Cachectin
General function
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-α, which prevents the binding of TNF-α to its receptors.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)The binding of human TNF by golimumab was shown to neutralise TNF-α-induced cell-surface expression of the adhesion molecules E-selectin, vascular cell adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1 by human endothelial cells. In vitro, TNF-induced secretion of interleukin (IL)-6, IL-8 and granulocyte-macrophage colony stimulating factor (GM-CSF) by human endothelial cells was also inhibited by golimumab.
Improvement in C-reactive protein (CRP) levels were observed relative to placebo groups and treatment with Simponi resulted in significant reductions from baseline in serum levels of IL-6, ICAM-1, matrix-metalloproteinase (MMP)-3 and vascular endothelial growth factor (VEGF) compared to control treatment. In addition, levels of TNF- were reduced in RA and AS patients and 15 levels of IL-8 were reduced in PsA patients. These changes were observed at the first assessment (week 4) after the initial Simponi administration and were generally maintained through week 24.
Original license holder
Marketing authorisation numbers
EU/1/09/546/001 - 008
Marketing authorisation holder
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands
Name of the manufacturer of the biological active substance
Janssen BiologicsB.V. Einsteinweg 101
NL-2333 CB Leiden
The Netherlands

Janssen Biologics (Ireland)
Barnahely
Ringaskiddy
Co. Cork
Ireland
Name and address of the manufacturer(s) responsible for batch releaseJanssen Biologics B.V.
Einsteinweg 101
NL-2333 CB Leiden
The Netherlands
Max shelf life
18 months
Storage conditions
2°C – 8°C
List of excipients
Sorbitol(E420)
L-histidine
L-histidine monohydrochloride monohydrate
Polysorbate 80
Water for injection
Evidentic Support
+49 (0) 30 959 99 8831

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