Unit:
Κατεύθυνση Οικονομία και Διοίκηση Υπηρεσιών ΥγείαςLibrary of the Faculty of Economics and of the Faculty of Business Administration
Author:
Dalagiorgos Apostolos
Supervisors info:
Ιωάννης Υφαντόπουλος, Ομότιμος Καθηγητής Οικονομικών της Υγείας και Κοινωνικής Πολιτικής, Τμήμα Πολιτικής Επιστήμης και Δημόσιας Διοίκησης, ΕΚΠΑ
Original Title:
Αξιολόγηση τεχνολογίας βιο-ομοειδών σκευασμάτων διεθνώς: προσεγγίσεις, μέθοδοι και αποτελέσματα
Translated title:
Technology assessment of biosimilar drugs internationally: Approaches, methods and results
Summary:
Background: Technological advancements have given the opportunity to researchers to produce modern drugs with active substunces coming from living organisms. These kind of drugs are called biological. After the patent expiration of biological drugs the industry can produce similar drugs, called biosimilars.
Methodology: This study is divided into two research sections. The first is a comprehensive literature review of published data (Google Scholar, PubMed) and a review of the websites of Health Technology Assessment Organizations (HTAs) for unpublished data. The data were analyzed qualitatively in order to draw useful conclusions about the scope of policy in Europe and the role of the Health Technology Assessment Organizations.
The second part also presents the results of a cross-sectional pilot study aimed to investigate the knowledge and beliefs of people working for pharmaceutical companies, conducted in September and October 2019 using a questionnaire. 91 people participated in the study while data were analyzed using the IBM SPSS 22.0 (Statistical Package for Social Sciences).
Results: The data we collected from the review of the existing evidence showed that biosimilars usually do not go through health technology assessments, while confirmed their efficacy and the patients’ ability to access innovative therapies at a lesser cost for the health systems.
The results of the pilot study showed that the majority of participants stated that they know what biosimilars are. However, the knowledge questions showed a relative lack of sufficient knowledge of the subject.
The majority of the participants believe that prescribing biosimilars should not be confined to primary patients alone and that there should be no automatic substitution of the reference drug at the pharmacy level. They also argued that wider use of biosimilars will increase patients' access to innovative therapies and that their use will save resources for the health system. In addition, they believed that biosimilars, generic and innovative medicines should go through the Health Technology Assessment Organization. Relationships were stratified by gender, age, years of work, sector of work and type of company.
Conclusion: A number of measures as in other European countries, are necessary in Greece regarding the use of biosimilars and better training of people working at the level of the pharmaceutical industry is also needed.
Main subject category:
Social, Political and Economic sciences
Keywords:
biologic drugs, biosimilars, health technology assesement, biosimilar approvals
