Analysis Highlights Fiscal, Access Benefits of Omalizumab Biosimilars in Europe

Biosimilars have been touted for years as a way to curb the soaring cost of biologic therapies—and fresh data suggest just how big that impact could be. A new analysis in the Journal of Medical Economics projects that an omalizumab biosimilar could save European health systems hundreds of millions of euros while widening access to care.¹

Omalizumab biosimilars promise significant savings for European health systems, enhancing access to vital therapies for patients with severe allergies. | Image credit: Alix - stock.adobe.com

Omalizumab, prescribed for severe allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP), represents a significant budgetary burden for European health systems. Currently, the US, European Union, and Canada each have 1 omalizumab biosimilar approved, all of which have approved Celltrion’s Omlyclo (also omalizumab-igec in the US).^2-4

At the time of the analysis, annual spending on the originator exceeded €787 million.¹ To assess the economic implications of biosimilar entry, investigators developed a 5-year budget impact model comparing scenarios with and without a biosimilar option.

The model compared 2 scenarios: one without biosimilar entry and another that incorporated a gradual uptake of an omalizumab biosimilar. Inputs for the analysis were drawn from national drug price databases, with initial assumptions including a modest market share uptake and a 30% discount relative to the originator.

Even under these conservative assumptions, the projections were significant. The analysis estimated savings of €40 million in the first year of biosimilar availability, growing to €640 million cumulatively over 5 years. Moreover, these savings could be reinvested to expand access, supporting treatment for an estimated 96,000 additional patients annually. At higher discount levels, the impact was even more pronounced. With a 50% discount, projected savings rose to €1.04 billion over 5 years, while a 70% discount scenario produced cumulative savings of €1.44 billion.

The authors noted that the model likely underestimates the true economic potential of an omalizumab biosimilar. Notably, it did not incorporate competitive price erosion from the originator, which typically follows biosimilar entry and can further reduce costs. In addition, the model did not account for indirect savings, such as reduced hospitalizations or decreased reliance on rescue medications, that may result from broader patient access to effective therapy. As a result, real-world outcomes could surpass the study’s baseline projections.

“This analysis supports biosimilars as a strategic tool for sustainable biologic therapy access in Europe,” the study authors concluded, emphasizing the link between cost efficiency and improved patient outcomes. By highlighting both the fiscal and clinical benefits, the research provides a data-driven rationale for payers and policymakers to prioritize biosimilar adoption strategies.

For health care systems under pressure to balance innovation with affordability, the implications are clear. Biosimilars such as omalizumab not only alleviate budgetary strain but also create opportunities to extend care to underserved patient populations. As the European market continues to evolve, proactive measures to encourage biosimilar uptake will be critical to achieving financial sustainability and ensuring equitable access to advanced biologic therapies.

References

1. Jang M, Lee J, Yi S, Kwon TS. Budget impact of introducing an omalizumab biosimilar in 23 European countries. J Med Econ. 2025;28(1):1639-1650. doi:10.1080/13696998.2025.2558450

2. Jeremias S. FDA approves first omalizumab biosimilar. The Center for Biosimilars^®. March 7, 2025. Accessed September 24, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-omalizumab-biosimilar

3. Jeremias S. Eye on pharma: biosimilar Ozempic; Celltrion omalizumab biosimilar submission. The Center for Biosimilars. April 4, 2024. Accessed September 24, 2025. https://www.centerforbiosimilars.com/view/eye-on-pharma-biosimilar-ozempic-biocon-mylan-merger-celltrion-omalizumab-biosimilar-submission

4. Jeremias S. Health Canada approves first omalizumab biosimilar. The Center for Biosimilars. December 16, 2024. Accessed September 24, 2025. https://www.centerforbiosimilars.com/view/health-canada-approves-first-omalizumab-biosimilar