Η διείσδυση των βιο-ομοειδών φαρμάκων στα συστήματα υγείας: ευκαιρίες και προκλήσεις
KeywordsΒιο-ομοειδή φάρμακα ; Βιολογικά φάρμακα ; Γενόσημα φάρμακα ; Βιοϊσοδυναμία ; Ανταλλαξιμότητα ; Αλλαγή θεραπείας ; Αδαλιμουμάμπη ; Πολιτική βιωσιμότητας
Nowadays, one of the major biotechnological tools in the treatment of chronic diseases is the biologic drugs (also known as ‘biologics’). Serious diseases, such as cancer and autoimmune diseases, are now manageable due to the mechanisms of biologics. These products are made from living organisms, and when their patent expires, another industry may produce a similar biological molecule. These biological molecules are called biosimilars. The purpose of this study is to present the mechanisms of biosimilars’ development, the regulatory framework of their production and authorization, as well as the consequences of their entry into health systems. In addition, the main issues that are analyzed are the comparison of biosimilars with generics, the critical issues of safety and exchangeability and the presentation of economic data over the last years of circulation in European markets. Τhis study is based on bibliography of recent research data. The conclusions are categorized by SWOT analysis to highlight the benefits and challenges of biosimilars penetration into health systems. The main purpose is to reduce government’s budget and pharmaceutical costs with the contribution of all stakeholders. Finally, this approach sets out proposals for the creation of a policy framework for the viability of the biosimilars’ market.