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. 2025 Sep;39(5):735-751.
doi: 10.1007/s40259-025-00732-2. Epub 2025 Aug 8.

Introduction of Biopharmaceuticals in Europe: A Cross-Sectional Study of Early Diffusion Patterns and Data Availability

Ivar Veszelei  1 , Brian Godman  2   3   4 , Katri Aaltonen  5   6 , Gisbert W Selke  7 , Kristina Garuolienė  8 , Agnese Cangini  9 , Amanj Kurdi  2   3 , António Teixeira Rodrigues  10   11 , Caridad Pontes  12   13 , Carla Torre  14   15 , Carlotta Lunghi  16   17 , Edel Burton  18   19   20 , Elita Poplavska  21 , Freyja Jónsdóttir  22   23 , Guenka Petrova  24 , Irene Langner  7 , Irina Iaru  25 , Irina Odnoletkova  26 , Juraj Slabý  27 , Katarina Gvozdanović  28 , Leena Saastamoinen  29 , Ott Laius  30 , Ria Benkö  31   32 , Silvija Žiogaitė  8 , Stuart McTaggart  33 , Tanja Mueller  2 , Thais de Pando  12   34 , Tomáš Tesař  35 , Zornitsa Mitkova  24 , Björn Wettermark  36   37
Affiliations

Introduction of Biopharmaceuticals in Europe: A Cross-Sectional Study of Early Diffusion Patterns and Data Availability

Ivar Veszelei et al. BioDrugs. 2025 Sep.

Abstract

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.

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Conflict of interest statement

Declarations. Funding: Open access funding provided by Uppsala University. The study was financed by local funds from Uppsala University. Conflict of interest: Agnese Cangini, Gisbert W. Selke, Irene Langner, Katri Aaltonen, Ott Laius, Thais de Pando, and Tomáš Tesař are affiliated with organizations involved in payer decision making and the reimbursement of medicines, although they may not be directly engaged in such activities. Juraj Slabý and Leena Saastamoinen are affiliated with organizations involved in health technology assessment in advisory or expert roles. Ivar Veszelei, Brian Godman, Kristina Garuolienė, Amanj Kurdi, António Teixeira Rodrigues, Caridad Pontes, Carla Torre, Carlotta Lunghi, Edel Burton, Elita Poplavska, Freyja Jónsdóttir, Guenka Petrova, Irina Iaru, Irina Odnoletkova, Katarina Gvozdanović, Ria Benkö, Silvija Žiogaitė, Stuart McTaggart, Tanja Mueller, Zornitsa Mitkova, and Björn Wettermark have no conflicts of interest related to payer or health technology assessment agencies. Ethics approval: This is an observational study using only national-level aggregated data and thus ethical approval was not required. Consent to participate: As only national-level aggregated data were used, patient consent to participate was not required. Consent for publication: Not applicable. Availability of data and material: All data of this study are available from the corresponding author upon reasonable request. Code availability: Not applicable. Author contributions: Ivar Veszelei and Björn Wettermark were responsible for the study's conception. All authors participated in designing the study, with Ivar Veszelei taking on overall management responsibilities, including organizing meetings, managing documentation, and facilitating clear communication among the team. Data management, collection, and analysis was performed by Ivar Veszelei. The first draft of the manuscript was written by Björn Wettermark based on a prior master thesis written by Ivar Veszelei, under supervision of BW. All authors reviewed various versions of the manuscript, provided feedback, and approved the final version.

Figures

Fig. 1
Fig. 1
Timeline of the selected biopharmaceuticals approved by the European Medicines Agency from 2015 to 2020. Anatomical Therapeutic Chemical codes, along with their International Nonproprietary Names; the fixed dose combination of insulin glargine & lixisenatide (A10AE54), evolocumab (C10AX13), alirocumab (C10AX14), dupilumab (D11AH05), follitropin delta (G03GA10), secukinumab (L04AC10), brodalumab (L04AC12), ixekizumab (L04AC13), sarilumab (L04AC14), guselkumab (L04AC16), tildrakizumab (L04AC17), risankizumab (L04AC18), erenumab (N02CD01), galcanezumab (N02CD02), fremanezumab (N02CD03), mepolizumab (R03DX09), benralizumab (R03DX10)
Fig. 2
Fig. 2
Overview of the final study population derived from the initially considered countries, resulting in 17 national and 2 regional cohorts with adequately comparable diffusion data
Fig. 3
Fig. 3
Availability of health authority data on a out-of-hospital, b hospital, and c wholesaler of biopharmaceuticals for this study over the initial 4 years post-market authorization. The shade of color represents availability. A darker shade indicates the availability of data at the specified level, while a lighter shade represents data that are limited to one of the other levels. Uncolored countries/regions were unable to provide any data
Fig. 4
Fig. 4
Distribution of out-of-hospital and hospital utilization across the selected countries and regions for a proprotein convertase subtilisin/kexin type 9 inhibitors, b all immunosuppressant antibodies, c the calcitonin gene-related peptide receptor antagonists, and d the interleukin-5 targeting therapies. Out-of-hospital utilization is represented in blue, while hospital utilization is shown in red. The accumulated diffusion numbers in defined daily doses per 1000 inhabitants for out-of-hospital utilization are displayed at the top of each bar, and for hospital utilization at the bottom of each bar
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