Golimumab
Therapeutic Golimumab antibody from the original Simponi® commercial drug.
Reference Standard as Aliquots
Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot | Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2018.06 |
Simponi® DE |
4 mg |
Unit: aliquot(s) |
540,00 €
/aliquot
|
|||
2019.03 |
Simponi® DE |
4 mg |
Unit: aliquot(s) |
540,00 €
/aliquot
|
|||
2025.03 |
Simponi® DE |
4 mg |
Unit: aliquot(s) |
540,00 €
/aliquot
|
Biosimilars as Aliquots
Access Batch Specific Analytical Information
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Product Information
Here you will find the product information for the reference product.
Simponi® / Golimumab Reference Product
| Drug name | Simponi® |
| INN | Golimumab |
| API type | Human 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 release | Janssen 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 |
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