Ustekinumab
Therapeutic Ustekinumab antibody from the original Stelara® commercial drug.
Reference Standard as Aliquots
Stelara®
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Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot
| Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2018.10 |
Stelara® DE |
4 mg |
Unit: aliquot(s) |
1.151,00 €
/aliquot
|
|||
2019.02 |
Stelara® DE |
4 mg |
Unit: aliquot(s) |
1.151,00 €
/aliquot
|
|||
2019.05 |
Stelara® DE |
4 mg |
Unit: aliquot(s) |
1.151,00 €
/aliquot
|
|||
2019.08 |
Stelara® DE |
4 mg |
Unit: aliquot(s) |
1.151,00 €
/aliquot
|
|||
2019.12 |
Stelara® DE |
4 mg |
Unit: aliquot(s) |
1.151,00 €
/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.
Stelara® / Ustekinumab Reference Product
| Drug name | Stelara® |
| INN | Ustekinumab |
| API type | Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin(IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology |
| Pharmacotherapeutic group | Immunosuppressants, interleukin inhibitors |
| ATC code | L04AC05 |
| Target of antibody | IL-12; Synonyms: CLMF, CLMF2, IL-12B, NKSF, NKSF2, p40, Il-12b, Il12p40, Il-12p40, Il12, IL-12p40, LOC100217488, IL-12p35, Il-12a, Ll12a, p35, IL12p40, IL12B, IL-12 p35 |
| General function | Ustekinumb is used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23. Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor protein expressed on the surface of immune cells. Ustekinumab cannot bind to IL-12 or IL-23 that is already bound to IL-12R1 cell surface receptors. Thus, ustekinumab is not likely to contribute to complement- or antibody-mediated cytotoxicity of cells with IL-12 and/or IL-23 receptors. IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells, and both cytokines participate in immune functions; IL-12 stimulates natural killer (NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 (Th1) phenotype, IL- 23 induces the T helper 17 (Th17) pathway. However, abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis and Crohn’s disease. By binding the shared p40 subunit of IL-12 and IL-23, ustekinumab may exert its clinical effects in psoriasis, psoriatic arthritis and Crohn’s disease through interruption of the Th1 and Th17 cytokine pathways, which are central to the pathology of these diseases. In patients with Crohn’s disease, treatment with ustekinumab resulted in a decrease in inflammatory markers including C-Reactive Protein (CRP) and fecal calprotectin during the induction phase, which were then maintained throughout the maintenance phase. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | |
| Original license holder | |
| Marketing authorisation numbers | EU/1/08/494/001 - 005 |
| Marketing authorisation holder | Janssen Sciences Ireland UC Barnahely Ringaskiddy Co. Cork Ireland |
| Name of the manufacturer of the biological active substance | Patheon Biologics LLC 4766 LaGuardia Drive St. Louis, MO 63134 USA Janssen Biologics B.V. Einsteinweg 101 NL-2333 CB Leiden The Netherlands |
| 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 | 36 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | EDTA disodium salt dihydrate L-histidine L-histidine monohydrochloride monohydrate L-methionine Polysorbate 80 Sucrose Water for injection |
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