Omalizumab Original Drug Aliquot | Anti-IgE | Therapeutic Monoclonal Antibody

Aliquoted from the original drug | Now available for research use

Aliquots of the original drug Omalizumab (Xolair®) are now available as research consumables.

Omalizumab drug aliquots can be used for in vitro or in vivo experiments. Several other reference drugs and biosimilars are also available.

The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed original drug.

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Multiple Batches

Up to 10 batches of original drugs for examining batch-to-batch variations

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Up to 80% less compared to the original pharmaceutical price

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Shipment within days worldwide according to GDP-standards

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Up to 80% less compared to the original pharmaceutical price

Xolair® / Omalizumab Reference Product

Drug nameXolair®
INNOmalizumab
API typeMonoclonal antibody
Pharmacotherapeutic group
Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases
ATC code
R03DX05
Target of antibody
IgE
General function
Short descriptionOmalizumab is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily highdose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Omalizumab binds to IgE and prevents binding of IgE to FcεRI (high-affinity IgE receptor) on basophils and mast cells, thereby reducing the amount of free IgE that is available to trigger the allergic cascade. Treatment of atopic subjects with omalizumab resulted in a marked down-regulation of FcεRI receptors on basophils. Treatment with Omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL4, IL-5, and IL-13 by innate, adaptive and non-immune cells.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)The in vitro histamine release from basophils isolated from Omalizumab-treated subjects was reduced by approximately 90% following stimulation with an allergen compared to pre-treatment values.
In clinical studies in allergic asthma patients, serum free IgE levels were reduced in a dose-dependent manner within one hour following the first dose and maintained between doses. One year after discontinuation of Omalizumab dosing, the IgE levels had returned to pre-treatment levels with no observed rebound in IgE levels after washout of the medicinal product.
Original license holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Marketing authorisation numbers
EU/1/05/319/001
Marketing authorisation holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Name of the manufacturer of the biological active substance
Novartis Pharma S.A.S.
Centre de Biotechnologie
8, rue de l’Industrie
F-68330 Huningue
France

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.
BioProduction Operations Singapore
8 Tuas Bay Lane
Singapore 636986
Singapore
Name and address of the manufacturer(s) responsible for batch releaseNovartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Max shelf life
4 years
Storage conditions
2°C – 8°C
List of excipients
Sucrose
L-histidine
L-histidine hydrochloride monohydrate
Polysorbate 20

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Our products are empowering researchers worldwide​

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.

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