Biosimilars
Omalizumab (Xolair)
Mechanism of Action: IgE receptor antagonists; Immunosuppressants Drug class: Monoclonal antibodies Originator: Genentech Developer: Dana-Farber Cancer Institute; Genentech; John Hopkins University; National Institute of Allergy and Infectious Diseases; Novartis Indication: Allergic asthma; Chronic urticaria; Nasal polyps
Market revenue of Omalizumab
Omalizumab (sold as Xolair) has shown a steady increase in global market revenue over the past five years, reflecting growing clinical use and expanded indications. Sales have consistently risen due to broader adoption in allergic asthma, chronic spontaneous urticaria, and newer indications such as food allergy, with reported revenue growth across major regions including the U.S. and internationally. For example, Roche’s financial reporting shows notable year-on-year increases in Xolair sales in both 2024 and the first half of 2025, driven by market expansion and increased uptake in existing and new treatment areas.
This upward trend aligns with broader market analyses that project continued growth for the omalizumab therapy segment, supported by rising prevalence of allergic conditions, expanding patient access, and clinician preference for targeted biologic treatment options.
Market revenue of Omalizumab (2020- till Q3 2025)
Fig 6: Market revenue of Omalizumab
Overall, omalizumab’s revenue trajectory over the last half-decade reflects stable and sustained demand, contributing to its position as a core biologic in the allergy/immunology market.
The Growing Impact of Omalizumab Biosimilars in 2026 and Beyond
The leading omalizumab biosimilar approved in the U.S. and Europe is Omlyclo (omalizumab-igec) from Celltrion. Approved by the FDA in March 2025 as the first interchangeable biosimilar for all Xolair indications—including asthma, chronic rhinosinusitis with nasal polyps, and food allergies—Omlyclo is expected to become available later in 2025 or 2026.
Expected Impact on Xolair Revenue
- Revenue Pressure: Analysts project a significant decline in sales for the original Xolair product, with revenue potentially dropping from $3.7 billion in 2023 to around $1.6 billion by 2029.
- Pricing Competition: Biosimilars typically launch 15–35% below the reference product, prompting the originator (Novartis) to offer discounts to retain market share. In real-world practice, competitive pricing often leads to even larger savings.
- Market Share Shift: The entry of Omlyclo introduces competition, driving healthcare providers and systems to adopt the more cost-effective biosimilar. In Europe, Omlyclo has already captured notable market share in some countries through competitive tender processes.
- Healthcare System Savings: The availability of omalizumab biosimilars is expected to deliver substantial cost savings for healthcare systems—potentially hundreds of millions of euros in Europe alone—allowing funds to be redirected toward treating more patients.