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.

Albert Szent Györgyi Health Centre Institute of Clinical Pharmacy University of Szeged Szeged Hungary

Antibiotic Policy Group Institute for Infection and Immunity City St George's University of London London UK

AOK Research Institute Berlin Germany

Área del Medicament Servei Català de la Salut Barcelona Spain

Belgian Health Care Knowledge Centre Brussels Belgium

Centre for Health Evaluation and Research Infosaúde National Association of Pharmacies Lisbon Portugal

Departament de Farmacologia de Terapèutica i de Toxicologia Universitat Autònoma de Barcelona Barcelona Spain

Department of Applied Pharmacy Faculty of Pharmacy and Institute of Public Health Riga Stradins University Riga Latvia

Department of Life Sciences Health and Health Professions Link Campus University Rome Italy

Department of Medical and Surgical Sciences University of Bologna Bologna Italy

Department of Organisation and Management in Pharmacy Faculty of Pharmacy Comenius University in Bratislava Bratislava Slovakia

Department of Organization and Economy of Pharmacy Faculty of Pharmacy Medical University of Sofia Sofia Bulgaria

Department of Pharmacoepidemiology Andrija Stampar Teaching Institute of Public Health Zagreb Croatia

Department of Pharmacy Faculty of Pharmacy Uppsala University Box 580 751 23 Uppsala Sweden

Department of Public Health Pharmacy and Management School of Pharmacy Sefako Makgatho Health Sciences University Pretoria South Africa

Estonian State Agency of Medicines Tartu Estonia

Faculdade de Farmácia da Universidade de Lisboa Lisbon Portugal

Faculty of Pharmaceutical Sciences University of Iceland Reykjavik Iceland

Faculty of Pharmacy Institute of Clinical Pharmacy University of Szeged Szeged Hungary

INVEST Research Flagship Centre University of Turku Turku Finland

Italian Medicines Agency Rome Italy

Laboratory of Systems Integration Pharmacology Clinical and Regulatory Science Research Institute for Medicines of the University of Lisbon Lisbon Portugal

Life and Health Sciences Research Institute School of Medicine University of Minho Campus de Gualtar Braga Portugal

Pharmaceutical Care Research Group School of Pharmacy University College Cork Cork Ireland

Pharmacology Physiology and Pathophysiology Department Faculty of Pharmacy Iuliu Hatieganu University of Medicine and Pharmacy Cluj Napoca Romania

Pharmacy and Pharmacology Center Faculty of Medicine Vilnius University Vilnius Lithuania

Pharmacy Department Bon Secours Hospital Cork Ireland

Pharmacy Services Landspitali University Hospital Hringbraut Reykjavik Iceland

Public Health Scotland Edinburgh UK

Research and Information Section Finnish Medicines Agency Helsinki Finland

School of Public Health University College Cork Cork Ireland

Servei de Farmacología Clínica Hospital de la Santa Creu i Sant Pau Barcelona Spain

State Institute for Drug Control Prague Czech Republic

Strathclyde Institute of Pharmacy and Biomedical Sciences University of Strathclyde Glasgow UK

The Social Insurance Institution of Finland Helsinki Finland

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