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

Andras Inotai, Marcell Csanadi, Guenka Petrova, Maria Dimitrova, Tomasz Bochenek, Tomas Tesar, Kristina York, Leos Fuksa, Alexander Kostyuk, Laszlo Lorenzovici, Vitaly Omelyanovskiy, Katalin Egyed, Z. Kaló

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Abstract

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.

Original languageEnglish
Article number9597362
JournalBioMed Research International
Volume2018
DOIs
Publication statusPublished - Jan 1 2018

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ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Microbiology(all)

Cite this

Inotai, A., Csanadi, M., Petrova, G., Dimitrova, M., Bochenek, T., Tesar, T., York, K., Fuksa, L., Kostyuk, A., Lorenzovici, L., Omelyanovskiy, V., Egyed, K., & Kaló, Z. (2018). Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts. BioMed Research International, 2018, [9597362]. https://doi.org/10.1155/2018/9597362