Ustekinumab

Name: Ustekinumab MKS17MB
SKU: 08000206_MKS17MB
Price: 1117.00 EUR
Availability: InStock

Therapeutic Ustekinumab antibody from the original Stelara® commercial drug.

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Product Batch	Antigen	Molecular Class	Drug Brand	Product Concentration	CoA	Quantity per vial	Storage Temperature	Expiry Date	Price from
Ustekinumab GKS1LMO	IL-12	Monoclonal Antibody	Stelara®	90 mg/mL	–	4 mg	-80°C	2018.10	1.005,30 €	view product Max: 10 Min: 1 Step: 1
Ustekinumab HCS1YMQ	IL-12	Monoclonal Antibody	Stelara®	90 mg/mL	–	4 mg	-80°C	2019.02	1.005,30 €	view product Max: 10 Min: 1 Step: 1
Ustekinumab HES3CMC	IL-12	Monoclonal Antibody	Stelara®	90 mg/mL	–	4 mg	-80°C	2019.05	1.005,30 €	view product Max: 10 Min: 1 Step: 1
Ustekinumab HIS2WMB	IL-12	Monoclonal Antibody	Stelara®	90 mg/mL	–	4 mg	-80°C	2019.08	1.005,30 €	view product Max: 10 Min: 1 Step: 1
Ustekinumab IAS1GMF.A	IL-12	Monoclonal Antibody	Stelara®	90 mg/mL	–	4 mg	-80°C	2019.12	1.005,30 €	view product Max: 10 Min: 1 Step: 1
Ustekinumab IDS2MMF	IL-12	Monoclonal Antibody	Stelara®	90 mg/mL	–	4 mg	-80°C	2021.04	1.005,30 €	view product Max: 2 Min: 1 Step: 1
Ustekinumab MKS17MB	IL-12	Monoclonal Antibody	Stelara®	90 mg/mL	–	4 mg	-80°C	2025.10	1.117,00 €	view product Max: 2 Min: 1 Step: 1

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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-12R1 receptor protein expressed on the surface of immune cells. Ustekinumab cannot bind to IL-12 or IL-23 that is already bound to IL-12R1 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