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BioMed Research International
Volume 2018 (2018), Article ID 9597362, 9 pages
Research Article

Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts

1Syreon Research Institute, Budapest, Hungary
2Department of Health Policy and Health Economics, Eötvös Loránd University (ELTE), Budapest, Hungary
3Department of Pharmaceutics and Central Clinical Pharmacy, University of Pécs, Pécs, Hungary
4Faculty of Pharmacy, Medical University-Sofia, Sofia, Bulgaria
5Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland
6Department of Organisation and Management in Pharmacy, Faculty of Pharmacy, Comenius University, Bratislava, Slovakia
7Management Center Innsbruck, Innsbruck, Austria
8Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Králové, Czech Republic
9Kazakh Agency for Health Technology Assessment, Astana, Kazakhstan
10Syreon Research Romania, Tirgu Mures, Romania
11Faculty of Technical and Human Sciences, Sapientia University, Tirgu Mures, Romania
12Center of Healthcare Quality Assessment and Control, Ministry of Health of the Russian Federation, Moscow, Russia
13Egis Pharmaceuticals, Budapest, Hungary

Correspondence should be addressed to Andras Inotai

Received 31 August 2017; Accepted 6 December 2017; Published 10 January 2018

Academic Editor: Joao Eurico Fonseca

Copyright © 2018 Andras Inotai et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection.