Xolair Manufacturer – About Genentech

David Fuller

Last Updated On: October 6, 2025

Founded in 1976, Genentech quickly became one of the world’s most influential biotechnology companies, helping shape the way modern medicine utilizes genetic engineering to create life-changing therapies. What began as a bold vision in the early days of biotechnology has grown into a global leader known for its commitment to science, innovation, and patient care.

Among Genentech’s major achievements is the development of Xolair (omalizumab), created in collaboration with Novartis and Tanox. This groundbreaking monoclonal antibody blocks immunoglobulin E (IgE), a key driver of allergic responses. Today, Xolair has FDA approval for several conditions, including moderate to severe allergic asthma, chronic spontaneous urticaria, nasal polyps, and more recently, IgE-mediated food allergies.

In this article, we’ll take a closer look at Genentech’s role as the manufacturer of Xolair, examining its history, leadership in biotechnology, and how this therapy continues to improve the lives of patients worldwide.

Key Takeaways

• Xolair (omalizumab) was co-developed by Genentech, Novartis, and Tanox, with Genentech overseeing U.S. manufacturing and Novartis leading global commercialization efforts.
• The therapy has regulatory approval for allergic asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy. It also has an established safety with decades of research and clinical use.
• Genentech ensures strict quality standards, regulatory compliance, and pharmacovigilance, making Xolair a trusted biologic therapy worldwide.
• Novartis plays a vital role in expanding patient access internationally, not just distributing but co-developing and promoting the therapy.
• As a biologic, Xolair does not have a generic alternative, though biosimilars may become available in the future.

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Genentech’s Role in the Development and Production of Xolair

Xolair (omalizumab) was not the work of a single company but the result of collaboration between Genentech, Novartis, and Tanox (later acquired by Genentech). Genentech leveraged its expertise as a pioneer in monoclonal antibody research, helping to translate decades of scientific knowledge into a targeted therapy that blocks IgE, the antibody central to allergic responses. This mechanism marked a breakthrough in the treatment of severe allergic conditions.

• Genentech continues to lead U.S. manufacturing and regulatory oversight, ensuring that each batch of omalizumab is produced under strict standards for sterility, consistency, and potency.
  
• The company also maintains extensive pharmacovigilance programs, gathering real-world safety data and refining clinical use guidelines.
  
• With Xolair as one of its flagship biologics, Genentech has reinforced its reputation as a trusted leader in allergy and immunology therapies.

Collaboration Between Genentech and Novartis in Xolair Distribution

The global success of Xolair reflects not just Genentech’s expertise but also its long-standing partnership with Novartis. Both companies were directly involved in clinical development, and today they share responsibilities for making omalizumab accessible worldwide.

• Genentech leads manufacturing and regulatory oversight in the United States, bringing its biologics expertise to production and safety management.
  
• Novartis, as a co-developer and global commercialization partner, has played a central role in expanding access to Xolair across Europe, Asia, and other international markets.
  
• Together, the companies ensure a reliable supply chain, minimizing shortages and responding to growing demand for biologic therapies.

This partnership demonstrates how shared innovation and global reach bring life-changing therapies to patients everywhere, supported by clear Xolair prescribing information that guides safe use across different healthcare systems.

Quality Standards, Regulatory Compliance, and Pharmacovigilance in Xolair Manufacturing

Producing a biologic like omalizumab requires uncompromising quality control. Genentech has established systems that ensure safety and efficacy from the laboratory stage to patient delivery.

Key Practices

• Full compliance with FDA and EMA biologics manufacturing standards, ensuring international consistency.
  
• Robust post-marketing surveillance to track side effects and update safety guidance.
  
• Distribution supported by detailed prescribing information on dosing, administration, and precautions.
  
• A transparent supply chain designed to prevent counterfeiting and protect patient access globally.

These measures give clinicians and patients confidence that every dose of Xolair meets the highest possible standards for safety and effectiveness.

Genentech’s Broader Portfolio and Leadership in Biologics Beyond Xolair

While Xolair is one of Genentech’s most recognizable therapies, the company’s impact spans much further. As a global leader in biologics and precision medicine, Genentech has built a portfolio that addresses oncology, immunology, and rare diseases.

• Cancer Therapies: Innovative biologics target HER2 and PD-L1 pathways, improving outcomes in breast cancer, lung cancer, and other tumors.
  
• Autoimmune Diseases: Therapies for conditions like rheumatoid arthritis highlight Genentech’s strength in immunology, with ongoing research in areas such as lupus.
  
• Rare Diseases: Genentech develops targeted biologics for underserved populations, advancing options where they have limited access to traditional treatments.

This breadth of innovation reflects Genentech’s enduring commitment to cutting-edge biologics and its capacity to support therapies like Xolair with the same rigor, safety, and vision.

Conclusion

Understanding the story of Xolair’s manufacturer story highlights how collaboration between Genentech, Novartis, and Tanox helped bring one of the most critical allergy and immunology biologics to patients worldwide. Genentech leads in U.S. manufacturing and regulatory oversight, while Novartis manages global commercialization. Together, they ensure safe and reliable access. 

From discovery to production, both companies have demonstrated decades of commitment to innovation, patient safety, and clinical excellence. Patients and providers can trust that Xolair will continue to be a cornerstone therapy for allergic asthma, urticaria, nasal polyps, and food allergy.

FAQs

1. Who makes Xolair?

Xolair is co-developed by Genentech, Novartis, and Tanox (later acquired by Genentech). Genentech oversees U.S. production, while Novartis manages global commercialization.

2. What is Genentech’s role in Xolair production?

Genentech leads manufacturing, U.S. regulatory compliance, and pharmacovigilance, ensuring every batch meets strict biologics standards.

3. How does Novartis contribute to Xolair availability?

Novartis is a co-developer and commercialization partner, helping expand Xolair access across Europe, Asia, and other regions worldwide.

4. Is Xolair available as a generic?

No. Xolair is a biologic, so it cannot have an identical generic. Instead, biosimilars may emerge in the future once patent and regulatory conditions allow.

References

EBSCO Research. Genentech is founded. https://www.ebsco.com/research-starters/history/genentech-founded

Genentech USA, Inc. Xolair (omalizumab) prescribing information. Revised March 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5238lbl.pdf