Budget Impact of Introducing an Omalizumab Biosimilar in 23 European Countries

Author(s)

Minyoung Jang, MSc, Joo Yeop Lee, BSc, Seungjae Yi, MA, Taek Kwon, MSc.
Celltrion, Incheon, Korea, Republic of.
OBJECTIVES: To assess the budgetary impact of introducing a biosimilar to omalizumab for the treatment of severe persistent allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP) across 23 European countries from a payer’s perspective, and to estimate the potential number of additional patients who could be treated with the resulting cost savings.
METHODS: A biosimilar market share uptake-based budget impact model (BIM) was developed in Microsoft Excel to compare two scenarios over a 5-year horizon: one without biosimilar introduction and a scenario with and a scenario without biosimilars. Market share evolution was modeled using country-specific previously launched biosimilar uptake as a proxy, while omalizumab usage growth was estimated using historical compound annual growth rates. Drug acquisition costs were sourced from national price databases, assuming a 30% discount for the biosimilar. As the actual cost of reimbursement from the payer's perspective is known to be lower than 30%, a sensitivity analysis with a 50% and 70% reduction was also conducted.
RESULTS: The introduction of an omalizumab biosimilar is projected to yield first year savings of €41 million, when discounted at 30% in comparison to the scenario where originator is only marketed. 5-year cumulative savings are estimated at approximately €631 million and could enable treatment access for an estimated 118,460 additional patients. Sensitivity analysis applying 50% and 70% discount rates project first-year savings of €66 million and €92 million, respectively, and cumulative five-year savings range from €920 million to €1.41 billion. These savings could support access for an estimated 259,159 to 587,456 additional patients over five years.
CONCLUSIONS: Adopting an omalizumab biosimilar across European healthcare systems could lead to substantial cost savings, providing opportunities to expand patient access and alleviate fiscal pressure.

Conference/Value in Health Info

2025-11, ISPOR Europe 2025, Glasgow, Scotland

Value in Health, Volume 28, Issue S2

Code

EE109

Topic

Economic Evaluation, Methodological & Statistical Research

Topic Subcategory

Budget Impact Analysis

Disease

Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)

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