Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?

BioDrugs, May 2025

Objective To evaluate the impact of demand- and supply-side policies on the biosimilar market penetration and identify effective strategies for promoting biosimilar uptake in eight high-income countries. Methods We analyzed biosimilar market penetration for infliximab, rituximab, and trastuzumab in six European countries—France, Germany, Italy, Spain, Sweden, and the UK—and two Asian countries—Japan and South Korea. Biosimilar market penetration was measured using two indicators: biosimilar market share and the time required for biosimilars to reach the majority point (> 50% market share). Policies were categorized into demand- and supply-side measures, and weights were applied to reflect the extent and timing of policy implementation. Spearman correlation examined the relationship between policy implementation and biosimilar market penetration. Results Sweden, Italy, and the UK showed the highest biosimilar market shares, adopting various demand-side policies, while Japan and South Korea exhibited slower biosimilar adoption with fewer or no demand-side policies. Biosimilars in most European countries reached the majority point within 5–6 quarters, while projections for Japan and South Korea exceeded 30 quarters. Correlation analysis revealed that adoption of demand-side policies was significantly associated with higher market share (rs = 0.69, p < 0.001) and shorter time to reach the majority point (rs = − 0.62, p < 0.01). In contrast, supply-side policies showed a weaker and less consistent association. Conclusions Demand-side policies, such as financial incentives and prescribing guidelines, are significantly associated with rapid and widespread biosimilar adoption, while supply-side policies had limited impact. Policymakers should prioritize demand-side measures to improve biosimilar uptake and reduce healthcare expenditures effectively.

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Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?

BioDrugs (2025) 39:635–644 https://doi.org/10.1007/s40259-025-00721-5 ORIGINAL RESEARCH ARTICLE Demand‑ Versus Supply‑Side Policies in Market Penetration of Biosimilars: Which is More Effective? Gyeongseon Shin1 · Heejin Han1 · Gyeyoung Choi1 · Donghwan Lee2 · SeungJin Bae1 Accepted: 7 April 2025 / Published online: 9 May 2025 © The Author(s) 2025 Abstract Objective To evaluate the impact of demand- and supply-side policies on the biosimilar market penetration and identify effective strategies for promoting biosimilar uptake in eight high-income countries. Methods We analyzed biosimilar market penetration for infliximab, rituximab, and trastuzumab in six European countries— France, Germany, Italy, Spain, Sweden, and the UK—and two Asian countries—Japan and South Korea. Biosimilar market penetration was measured using two indicators: biosimilar market share and the time required for biosimilars to reach the majority point (> 50% market share). Policies were categorized into demand- and supply-side measures, and weights were applied to reflect the extent and timing of policy implementation. Spearman correlation examined the relationship between policy implementation and biosimilar market penetration. Results Sweden, Italy, and the UK showed the highest biosimilar market shares, adopting various demand-side policies, while Japan and South Korea exhibited slower biosimilar adoption with fewer or no demand-side policies. Biosimilars in most European countries reached the majority point within 5–6 quarters, while projections for Japan and South Korea exceeded 30 quarters. Correlation analysis revealed that adoption of demand-side policies was significantly associated with higher market share (rs = 0.69, p < 0.001) and shorter time to reach the majority point (rs = − 0.62, p < 0.01). In contrast, supply-side policies showed a weaker and less consistent association. Conclusions Demand-side policies, such as financial incentives and prescribing guidelines, are significantly associated with rapid and widespread biosimilar adoption, while supply-side policies had limited impact. Policymakers should prioritize demand-side measures to improve biosimilar uptake and reduce healthcare expenditures effectively. 1 Introduction Key Points Biologic therapies have provided significant clinical benefits for patients across a range of severe and chronic conditions, including rheumatoid arthritis, diabetes, certain gastrointestinal disorders, and various forms of cancer [1–3]. Despite their therapeutic advantages, biologics have placed Various policy measures were introduced to enhance biosimilar uptake, yet few studies have explored the relative importance of demand-side and supply-side policies. Gyeongseon Shin and Heejin Han contributed equally. Demand-side policies play a stronger and more consistent role in improving biosimilar market penetration than supply-side policies. * Gyeongseon Shin * SeungJin Bae 1 College of Pharmacy, Ewha Womans University, Seoul, South Korea 2 Department of Statistics, Ewha Womans University, Seoul, South Korea substantial financial pressure on healthcare systems worldwide. In the USA, for example, biologic drugs comprise only about 2% of all prescribed medications but account for nearly 40% of total prescription drug expenditure [4]. Moreover, spending on biologics is anticipated to grow further in the coming years [5]. Vol.:(0123456789) 636 When patents for biologic medicines expire, biosimilars—highly similar and therapeutically similar versions of the original biologic drugs—can enter the market. These products typically offer comparable efficacy and safety profiles at lower prices, with price reductions of around 40% in some European countries [6]. The launch of biosimilars decreases the financial burdens on healthcare budgets by increasing market competition and reducing treatment costs [7]. In several countries, adopting biosimilars has led to measurable cost savings. In the USA, projected savings from biosimilars between 2021 and 2025 are estimated to reach US $38.4 billion [5]. Similarly, in countries where adalimumab biosimilars were made available, consumption increased by 1.0 standard units per 1000 people (p = 0.02) while spending significantly decreased (− $371.0 USD per gross domestic product per capita; p = 0.03) over four quarters [8]. These savings could support aging populations’ increased access to medications and finance new, highpriced orphan drugs [9, 10]. Despite these demonstrated benefits, the uptake of biosimilars faces several barriers, including prescriber hesitancy, lack of patient familiarity, patent litigation, and variations in pricing and reimbursement policies across different countries [4, 11]. To overcome these challenges, policymakers have implemented diverse demand-side policies (targeting healthcare providers or patients, such as financial incentives and prescribing guidelines) or supplyside policies (targeting pharmaceutical companies, such as price linkage) to encourage biosimilar adoption [12]. However, the success of these efforts has varied, indicating the need for more comprehensive analyses of policy effectiveness. It is generally accepted that policy measures significantly influence the adoption of biosimilars [13, 14], and health authorities and payers frequently use biosimilar market penetration (biosimilar uptake) as a key indicator to measure their impact. For example, the National Health Service (NHS) England explicitly established uptake targets, aiming for 90% of new patients and 80% of existing patients within 1 year of biosimilar market entry [15]; similarly, the 2018‒2022 French National Health Strategy aimed at increasing biosimilar use through a target of 80% biosimilar penetration by 2022 [16]. While the impact of biosimilars can also be assessed using various other parameters, such as improved patient access to treatments and cost reductions [17], this study focuses on uptake as an indicator because it directly reflects the extent to which biosimilars are utilized in clinical practice. Ultimately, this research seeks to inform evidence-based policymaking, supporting the design and refining of interventions that promote biosimilar use and bolster healthcare sustainability. G. Shin et al. 2 Methods 2.1 Data We compiled the quarterly sales volumes of originators and biosimilars for infliximab, rituximab, and trastuzumab for the period from July 2012 to June 2020 (32 quarters) from the Multinational Integrated Data Analysis System (IQVIA-MIDAS ® ). The IQVIA-MIDAS ® database provides comprehensive global sales data on pharmaceutical manufacturers’ sales to retail and hospital pharmacies [18]. This database is widely recognized for its reliability and has been utilized in numerous cross-national studies and market penetration analyses of biosimilars [14, 19–22]. Sales volume data were measured in standard units (SU). The SU represents the number of standard “dose” units sold—a (...truncated)


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Gyeongseon Shin, Heejin Han, Gyeyoung Choi, Donghwan Lee, SeungJin Bae. Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?, BioDrugs, 2025, pp. 635-644, Volume 39, DOI: 10.1007/s40259-025-00721-5