ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
This article is part of the Research TopicBiologic Drugs for immune-mediated inflammatory diseases (IMIDs) and Vaccines for infections: Validation, Drug-Utilization, Effectiveness, Regulation, Costs, and Safety in the real worldView all 6 articles
A comparative analysis of biologics market dynamics in 12 countries: (Bio)similar and sustainability
Provisionally accepted
- 1Ewha Womans University College of Pharmacy, Seodaemun-gu, Republic of Korea
- 2Yonsei University College of Pharmacy, Incheon, Republic of Korea
- 3Ewha Womans University, Seoul, Republic of Korea
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Objective: We sought to evaluate the relationship between biosimilar introduction and the prices and expenditures of biologics in high-income countries. Methods: This study examined IQVIA-MIDAS sales data for biologics and biosimilars from January 2018 to June 2020 across 12 high-income countries (Australia, Austria, Canada, France, Germany, Italy, Japan, Korea, Spain, Sweden, Switzerland, and the United Kingdom). We selected seven biologics that fall under the World Health Organization Anatomical Therapeutic Chemical code L (Antineoplastic and immunomodulating agents), and categorized them into two groups based on the availability of biosimilar data. Group A consisted of biologics with biosimilars-etanercept, infliximab, rituximab, and trastuzumab, while Group B comprised biologics without biosimilars, including cetuximab, nivolumab, and pembrolizumab. A descriptive analysis was conducted to investigate the association between biosimilar introduction and trends in Fisher price index and relative expenditure. In addition, two-sample t-test and Wilcoxon rank-sum test were used to assess the statistical significance of differences in growth rates between the two groups. Results: Group A exhibited a declining trend in the Fisher price index, whereas Group B remained stable across most countries, with average compound quarterly growth rates being -2.19% and - 0.54%, respectively (p<0.001). Relative expenditure trends also revealed contrasting patterns between the groups across most countries, further highlighting the differences. The average compound quarterly growth rates for relative expenditures was -1.78% for Group A and 7.66% for Group B (p<0.001). Conclusion: The introduction of biosimilars was significantly associated with reductions in the prices and expenditures of biologics in high-income countries. This underscores the potential role of biosimilars in suppoprting the long-term sustainability of the healthcare system.
Keywords: biosimilar, Market dynamics, Price index, Expenditure, Healthcare systemsustainability
Received: 04 Jul 2025; Accepted: 27 Oct 2025.
Copyright: © 2025 Song, Shin, Choi, Han and Bae. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: SeungJin Bae, sjbae@ewha.ac.kr
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