Golimumab drug aliquots can be used for in vitro or in vivo experiments. For biosimilar development, different batches of Golimumab drug can be ordered at the same time. Several other reference drugs are also available.
The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed reference drug.
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Up to 10 batches of original drugs for examining batch-to-batch variations
Up to 80% less compared to the original pharmaceutical price
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Up to 80% less compared to the original pharmaceutical price
| 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 |
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.
Evidentic GmbH
Am Mühlenberg 10
14476 Potsdam | Germany
