Biosimilar uptake policies in Europe: a cross-country mixed-methods policy analysis.

Background: European countries implemented a range of policies to enhance uptake of biosimilar medicines, which are interchangeable with the originator but usually offer biological therapies at lower cost. However, challenges to biosimilar uptake persist. The study analysed the effectiveness of policies to improve biosimilar uptake. Methods: Based on 2024 IQVIA MIDAS® data, biosimilar market shares were determined for 27 European countries. Data on supply-side policies (i.e., targeting price and funding) and demand-side policies (i.e., addressing stakeholders) implemented across the countries was obtained from information generated by the Pharmaceutical Pricing and Reimbursement Information (PPRI) network and validated by country experts. Biosimilar market shares were analysed in relation to the policies implemented in each country. Selected case studies illustrated how biosimilar uptake developed before and after the introduction of a policy. A literature review identified evaluations of biosimilar policies implemented individually or as a package. Findings: Biosimilar market shares varied substantially across Europe, ranging from above 50% (e.g., Norway, Italy) to below 10% (Greece, Luxembourg). All countries studied had biosimilar policies in place, but their design varied. Frequent policies were tendering, encouraging prescribers to switch medication from the originator to the biosimilar, and price setting based on the originator's price (biosimilar price link). Gain-sharing models, switching, the biosimilar price link and prescribing quotas were associated with higher biosimilar market shares. Interpretation: The study confirmed the importance of implementing policies and suggested that demand-side measures are particularly effective in increasing biosimilar uptake. Funding: European Commission under the EU4Health Programme.