Influence of European Market Dynamics on Biosimilars Market Share

• Main Authors: Diogo Pires, João Gonçalves
• Format: Article
• Language: English
• Published: Formifarma, LDA. 2016-10-01
• Series: Revista Portuguesa de Farmacoterapia
• Subjects: Biological Products/economics; Biosimilar Pharmaceuticals/economics; Drug Approval; Drug Costs; Economic Competition; Europe; European Union; Legislation; Drug
• Online Access: http://revista.farmacoterapia.pt/index.php/rpf/article/view/130
• ISSN: 1647-354X; 2183-7341

Introduction: Innovative biologic medicines have been linked to a skyrocketing cost which introduces high pressures on the already constrained national health budgets. The adoption of biosimilars (similar versions of an approved biologic reference product) allows to expand patients’ access to costly therapies, increasing the diversity of treatment options and attenuating national health budget pressures, releasing resources that can be used in other areas. Despite this advantage, biosimilars’ European market is not yet fully established and it is common to observe high variances in biosimilars’ adoption among European Union Member States due to unawareness of the dynamics that rule the market. Therefore, the present study aims to identify the most relevant dynamics of the EU biosimilars’ market and to access the influence of those in the market share obtained by these medicines in 10 years. Methods: In order to do so, it is performed a statistical study based on a 22 European Union countries’ sample for which are obtained a total of 11 market dynamics (independent variables) whose correlation with market share (dependent variable) is accessed through multiple linear regression using the statistical method ANOVA. Results: The results achieved comprise three mathematical models which confirm the influence of three market dynamics in a biosimilars’ market share. Conclusion: In what refers to European mature markets (epoetin, filgrastim, and somatropin), biosimilars’ market share increases 0.7% by every 1% price reduction introduced by the respective biosimilar (in the biosimilar + reference product segment) and it decreases 12.9% for every year that a biosimilar of the same class is present in the respective country and 16.3% for every year between the centralized market introduction authorization approval and the national entrance of the given biosimilar.