TY - JOUR
T1 - Introduction of Biopharmaceuticals in Europe
T2 - A Cross-Sectional Study of Early Diffusion Patterns and Data Availability
AU - Veszelei, Ivar
AU - Godman, Brian
AU - Aaltonen, Katri
AU - Selke, Gisbert W
AU - Garuolienė, Kristina
AU - Cangini, Agnese
AU - Kurdi, Amanj
AU - Rodrigues, António Teixeira
AU - Pontes, Caridad
AU - Torre, Carla
AU - Lunghi, Carlotta
AU - Burton, Edel
AU - Poplavska, Elita
AU - Jónsdóttir, Freyja
AU - Petrova, Guenka
AU - Langner, Irene
AU - Iaru, Irina
AU - Odnoletkova, Irina
AU - Slabý, Juraj
AU - Gvozdanović, Katarina
AU - Saastamoinen, Leena
AU - Laius, Ott
AU - Benkö, Ria
AU - Žiogaitė, Silvija
AU - McTaggart, Stuart
AU - Mueller, Tanja
AU - de Pando, Thais
AU - Tesař, Tomáš
AU - Mitkova, Zornitsa
AU - Wettermark, Björn
N1 - Publisher Copyright: © The Author(s) 2025.
PY - 2025/9
Y1 - 2025/9
N2 - BACKGROUND AND OBJECTIVES: Biopharmaceuticals add value in the treatment of many diseases but different health systems in Europe face clinical and economic challenges with introducing them. Joint efforts across Europe are therefore essential to ensure their sustainable and equitable use. However, to date few cross-national comparative studies have assessed their introduction. This study aimed to assess the availability of health authority data and variation in the early diffusion of biopharmaceuticals across Europe.METHODS: A cross-sectional study was undertaken to analyze the diffusion of 17 biopharmaceuticals, approved between 2015 and 2019, among European countries between 2015 and 2022. The study assessed data availability, diffusion rates measured as accumulated defined daily doses per 1000 inhabitants, as well as relative rankings between countries during the first 4 years following market authorization.RESULTS: Twenty countries and two regions out of 31 European countries provided data on biopharmaceutical utilization for out-of-hospital care, 15 provided wholesaler data, and 14 provided hospital data. Certain countries and regions contributed data in multiple categories, while six did not provide any data. Diffusion rates were assessed for 17 countries and two regions, which showed appreciable variation, with secukinumab and erenumab being introduced in most countries and follitropin delta and tildrakizumab in the least number of countries. Germany, Austria, and Norway demonstrated the highest early diffusion rates, while Lithuania, Romania, and Latvia had the lowest.CONCLUSIONS: This study revealed a substantial variation between European countries and regions in the early diffusion of biopharmaceuticals and the availability of data to monitor their use. The reasons behind these patterns require further investigation to support European countries in optimizing the use of biopharmaceuticals to reach an equitable and cost-effective use of medicines across Europe.
AB - BACKGROUND AND OBJECTIVES: Biopharmaceuticals add value in the treatment of many diseases but different health systems in Europe face clinical and economic challenges with introducing them. Joint efforts across Europe are therefore essential to ensure their sustainable and equitable use. However, to date few cross-national comparative studies have assessed their introduction. This study aimed to assess the availability of health authority data and variation in the early diffusion of biopharmaceuticals across Europe.METHODS: A cross-sectional study was undertaken to analyze the diffusion of 17 biopharmaceuticals, approved between 2015 and 2019, among European countries between 2015 and 2022. The study assessed data availability, diffusion rates measured as accumulated defined daily doses per 1000 inhabitants, as well as relative rankings between countries during the first 4 years following market authorization.RESULTS: Twenty countries and two regions out of 31 European countries provided data on biopharmaceutical utilization for out-of-hospital care, 15 provided wholesaler data, and 14 provided hospital data. Certain countries and regions contributed data in multiple categories, while six did not provide any data. Diffusion rates were assessed for 17 countries and two regions, which showed appreciable variation, with secukinumab and erenumab being introduced in most countries and follitropin delta and tildrakizumab in the least number of countries. Germany, Austria, and Norway demonstrated the highest early diffusion rates, while Lithuania, Romania, and Latvia had the lowest.CONCLUSIONS: This study revealed a substantial variation between European countries and regions in the early diffusion of biopharmaceuticals and the availability of data to monitor their use. The reasons behind these patterns require further investigation to support European countries in optimizing the use of biopharmaceuticals to reach an equitable and cost-effective use of medicines across Europe.
UR - https://www.scopus.com/pages/publications/105012717306
U2 - 10.1007/s40259-025-00732-2
DO - 10.1007/s40259-025-00732-2
M3 - Article
C2 - 40779010
SN - 1173-8804
VL - 39
SP - 735
EP - 751
JO - BioDrugs
JF - BioDrugs
IS - 5
ER -