Xolair® – Omalizumab Injection

Xolair® – Omalizumab Injection | U.S.-Manufactured Global Supply Monoclonal Antibody

Product Overview

Xolair® (omalizumab) is a recombinant humanized monoclonal antibody (IgG1κ) developed by Genentech, Inc. (a member of the Roche Group) and Novartis Pharmaceuticals. It is the first anti-IgE monoclonal antibody approved globally for the treatment of moderate to severe allergic asthma, chronic spontaneous urticaria (CSU), and other IgE-mediated allergic conditions.

The Xolair® product offered here is manufactured in the United States by the originator company and supplied through the official global distribution chain. While packaging and labeling are adapted for destination country compliance (e.g., language, regulatory marks), the formulation, device, and manufacturing quality are 100% identical to the U.S.-market version.

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Key Features & Advantages

• ✅ Original Brand, U.S.-Made by Genentech / Novartis
  Not a biosimilar. Manufactured under strict FDA and cGMP compliance.

• ✅ Biologically Identical to U.S.-Marketed Xolair®
  Only packaging language may differ for international regulatory purposes.

• ✅ Proven Mechanism Against IgE-Mediated Inflammation
  Extensively studied and used in both respiratory and dermatological indications.

• ✅ Multiple Indications Globally
  Approved for moderate to severe allergic asthma (≥6 years), chronic spontaneous urticaria (≥12 years), and nasal polyps (in some regions).

• ✅ Distributed via Global Supply Chain
  Available to licensed importers, hospitals, and regulatory-approved partners worldwide.

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Product Specifications

• Product Name: Xolair® (omalizumab injection)

• Active Ingredient: Omalizumab (recombinant humanized monoclonal antibody, IgG1κ)

• Strength / Form: 75 mg or 150 mg per vial (lyophilized powder); single-use

• Administration: Subcutaneous injection

• Manufacturer: Genentech, Inc. (USA) / Novartis Pharmaceuticals

• Packaging: International version with destination-specific labeling; identical formulation as U.S. version

• Storage: 2°C–8°C refrigerated; protect from light

• Shelf Life: 18–24 months depending on batch

• Supply Category: Originator biologic; not a biosimilar or generic substitute

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Mechanism of Action

Xolair® works by binding to free circulating IgE, thereby preventing its interaction with FcεRI receptors on mast cells and basophils. This reduces the allergic inflammatory cascade and helps stabilize immune response in conditions where IgE plays a central pathological role.

It is particularly effective in:

• Reducing asthma exacerbation frequency

• Improving control of chronic urticaria

• Minimizing use of corticosteroids in long-term allergy management

More info: NIH Omalizumab Mechanism Overview

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Use Cases in Global Supply

• Licensed importers supplying hospitals and allergy clinics

• Cross-border institutional procurement under legal frameworks

• Research hospitals conducting original biologic comparison studies

• Academic centers studying IgE-mediated disorders

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Compliance Statement

This product is manufactured in the United States by Genentech and Novartis, and is part of the official global supply chain. The formulation, quality, and pharmacological profile are identical to the U.S.-market version. Packaging and labeling are customized for compliance with local regulatory requirements in the export destination. This product is not a biosimilar. All importers and users must ensure compliance with local laws and licensing requirements.

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Tags / Keywords

Xolair Global Supply, Omalizumab Original Biologic, Anti-IgE Antibody, Chronic Urticaria Treatment, Severe Allergic Asthma Therapy, U.S.-Manufactured Xolair, Monoclonal Antibody for Allergy, Global Distribution Biologic, Genentech Novartis MAb, FcεRI Blocker