When it comes to treatments like Xolair (omalizumab), confidence in the manufacturers is essential for both patients and clinicians. Genentech and Novartis Pharmaceuticals Corporation are the trusted partners behind the development and marketing of Xolair. Together, they ensure that the production of this biologic therapy meets the highest global standards.
Under the FDA’s Current Good Manufacturing Practice (CGMP) regulations, both companies are committed to maintaining the safety, potency, and consistency of Xolair. Their dedication to robust quality systems and comprehensive pharmacovigilance programs guarantees the medication’s reliability for those who need it.
In this article, we’ll delve into the roles of Genentech and Novartis in bringing Xolair to patients, review their responsibilities in regulatory compliance and supply management, and explain how this impacts both healthcare providers and patients.
Key Takeaways
- Xolair (omalizumab) is developed and marketed through a collaboration between Genentech and Novartis. They combine Genentech’s clinical expertise with Novartis’s global distribution capabilities.
- The FDA has approved Xolair for allergic asthma, chronic spontaneous urticaria, food allergies, and chronic rhinosinusitis with nasal polyps (CRSwNP). Its dosing tailored to IgE levels and body weight.
- Both companies maintain high manufacturing standards and pharmacovigilance systems to ensure the safety and quality of Xolair. They update the prescribing information and patient materials as needed.
- Genentech and Novartis provide extensive support for healthcare providers. This includes dosing guides, safety communications, and training programs for self-administration and patient education.
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Overview Of Genentech And Novartis Collaboration In Developing And Distributing Xolair
The collaboration between Genentech Inc. and Novartis has been instrumental in the development and marketing of Xolair (omalizumab), a treatment that has helped many patients manage allergic conditions. This partnership combines Genentech’s expertise in biologics development with Novartis’s expansive global commercial infrastructure. Together, they have worked since 1996, with a focus on developing specific anti-IgE antibodies like Xolair.
Genentech led the clinical development of Xolair and prepared regulatory submissions. They based these on pivotal trials for allergic asthma and chronic spontaneous urticaria. Meanwhile, Novartis handled the global regulatory filings, marketing, and commercial launches across multiple regions.
This well-coordinated collaboration has led to the successful marketing and distribution of Xolair. Through their partnership, Genentech and Novartis provide crucial Xolair prescribing information, safety materials, and trial data. Through this, healthcare providers can safely administer Xolair injections and monitor treatment outcomes. Novartis also plays a key role in issuing regulatory updates and media releases whenever there are changes in approvals or indications for Xolair.
Additionally, Genentech and Novartis Ophthalmics reached an agreement in 2003. Under this, Genentech retained marketing rights for Lucentis (ranibizumab injection) in North America, while Novartis Ophthalmics holds exclusive commercialization rights outside North America. Lucentis is FDA-approved for several eye conditions, including neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema.
Historical Context: Regulatory Milestones And FDA Approval Timeline For Omalizumab
Understanding the regulatory approvals for Xolair and other medications is essential for healthcare providers and patients alike. It builds trust in the treatment’s safety and effectiveness. These regulatory approvals not only ensure public health but also provide healthcare professionals with a detailed product guide, including prescribing information.
- Initial U.S. Approval: Xolair first gained FDA approval in 2003 for the treatment of moderate to severe allergic (IgE-mediated) asthma in patients 12 years and older.
- Chronic Spontaneous Urticaria (CSU): In 2014, Xolair received FDA approval for CSU in patients aged 12 years and older who remained symptomatic despite antihistamine treatment.
- Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): In 2020, Xolair received FDA approval for the treatment of CRSwNP in patients 18 years of age and older whose condition was uncontrolled on intranasal corticosteroids.
- Food Allergy: In 2024, the FDA approved Xolair to reduce allergic reactions after accidental ingestion in patients aged 1 year and older with one or more food allergies.
At the time of its initial approval, Xolair was the first anti-IgE monoclonal antibody approved for clinical use. This marks a groundbreaking approach to treating allergic-related diseases.
Manufacturing Standards, Pharmacovigilance Systems, And Global Distribution Networks
Both Genentech and Novartis produce omalizumab using validated, cGMP-compliant processes for the production of recombinant monoclonal antibodies. They perform in-process tests and release tests to ensure the purity, potency, and sterility of each batch. Xolair is available in different presentations, including:
- Vials
- Prefilled syringes
- Autoinjectors
To ensure ongoing patient safety, both companies operate robust pharmacovigilance systems to collect spontaneous reports and conduct post-authorization safety studies. As new safety data emerges, this information leads to label updates, revisions to patient materials, and the implementation of risk-minimization activities. They also update the Xolair prescribing information and patient guides as needed to comply with regulatory requirements.
The collaboration between Genentech and Novartis supports the phased expansion of Xolair’s indications and broad market access. Their global distribution networks help manage supply, disseminate safety notices, and coordinate recalls if necessary.
The Role Of Genentech And Novartis In Biosimilar Development And Clinician Support
While omalizumab biosimilars would follow separate regulatory pathways, Genentech and Novartis continue to play a critical role in supporting clinicians who prescribe Xolair. They provide updated prescribing information, dosing guides, and safety communications to ensure healthcare providers have the tools they need for optimal care.
In addition, they provide implementation tools, such as training programs on injection techniques and indication-specific guidance. This supports safe administration and enhances patient education.
Additionally, they also supply implementation tools, such as training programs for treatment injection and indication-specific guidance to support safe administration and patient education.
Conclusion
The collaboration between Genentech and Novartis has been essential to the development and distribution of Xolair, combining Genentech’s clinical expertise with Novartis’s global reach. This partnership has allowed Xolair to evolve into a vital treatment for a range of allergic conditions since its initial FDA approval in 2003.
Both companies maintain high manufacturing standards and robust pharmacovigilance systems, ensuring Xolair‘s safety and quality for patients worldwide. Through their collaboration, they ensure that the latest prescribing information, safety updates, and patient education materials reach healthcare providers, helping them deliver the best possible care for their patients.
FAQs
1. Who are the manufacturers of Xolair?
Xolair is manufactured by Genentech and Novartis Pharmaceuticals Corporation, who collaborate on its development and distribution.
2. What regulatory approvals has Xolair received?
Xolair was approved by the FDA in 2003 for allergic asthma. It has since received approvals for chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and food allergies.
3. How do Genentech and Novartis ensure the safety and quality of Xolair?
Both companies follow strict Good Manufacturing Practices (cGMP) and have robust pharmacovigilance systems in place to monitor safety and product quality. They update the Xolair prescribing information regularly to maintain consistent product integrity.
References
U.S. Food and Drug Administration. Current Good Manufacturing Practice (CGMP) Regulations. U.S. Food and Drug Administration. Published December 29, 2023. Accessed November 5, 2025. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
Genentech Inc. Genentech: Xolair® (omalizumab) – Information for Patients. www.gene.com. Accessed November 5, 2025. https://www.gene.com/patients/medicines/xolair
