Therapeutic TNF-α-antibody from the original Simponi® commercial drug targeting the TNF-α-antigen, also referred to as Simponi® or golimumab antibody. Research-relevant quantities are available as licence-free consumable in aliquoted or diluted variant. Therapeutic monoclonal antibodies can be used from researchers in in vitro and in vivo experiments, biosimilar developers can order different batches at the same time.
What our clients say
”Evidentic can supply different batches of reference products for precilinical research.The quick access to the on-stock batches allows for adhoc ordering, keeps costs down and makes a headstart possible!”
“Evidentic is a new source of cost-efficient therapeutic mAbs for our immonassays. And easy to order!”
“We develop innovative and biosimilar mAbs for a global market. Evidentic’s aRMPs are a great source of cost-efficient reference products for our research and development program.”
“Evidentic gives rapid access to originator biologics and different batches. For biosimilar developers and regulators, it will shorten the time to gauge the analytical acceptance range for multiple CQAs of biotherapeutics.”
Golimumab / Simponi
|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
|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
(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.
2333 CB Leiden
|Name of the manufacturer of the biological active substance||Janssen BiologicsB.V. Einsteinweg 101
NL-2333 CB Leiden
Janssen Biologics (Ireland)
|Name and address of the manufacturer(s) responsible for batch release||Janssen Biologics B.V.
NL-2333 CB Leiden
|Max shelf life||18 months
|Storage conditions||2°C – 8°C
|List of excipients||Sorbitol(E420)
L-histidine monohydrochloride monohydrate
Water for injection