Unit:
Κατεύθυνση Κλινικές Μελέτες: Σχεδιασμός και ΕκτέλεσηLibrary of the School of Health Sciences
Author:
Petrichou Cristina-Maria
Supervisors info:
Καραμούζης Μιχαήλ, Επίκουρος Εαθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Καστρίτης Ευστράτιος, Αναπληρωτής Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Τέρπος Ευάγγελος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Original Title:
Η διαδικασία ανάπτυξης biosimilars - προκλήσεις και ερωτήματα
Translated title:
Biosimilars development process - challenges and questions
Summary:
During the recent era of scientific achievements biosimilars consist one of the major biotechnological
tools regarding the treatment of chronic diseases. With their contribution multiple serious diseases such as
cancer are now manageable permitting patients to access high quality treatment with low cost. Biosimilars
are products with similar activity with typical biological pharmaceutic products and their production is
possible when their patent expires.
Despite their powerful presence in the health domain and the elevated expectations created
towards promoting patients’ access to therapeutic interventions of low cost, the attitudes and beliefs of
health workers remain reluctant. Enabling reliable notification regarding biosimilarity and switching may
reinforce promoting of biosimilars’ use by contributing to their dynamic incorporation in the
contemporary pharmaceutical market.
The present study analyzes the characteristics of biosimilars, the mechanisms of their
development and the regulatory framework of their authorization. Furthermore it approaches the
consequences of their entry into health systems and of their prescription to patients. Their comparison to
biologics and generics is also presented. Additionally critical issues regarding safety and effectiveness are
examined as well as the increased possibility of immunization that biosimilars provoke. The influence of
health workers’ attitudes regarding their incorporation into the therapeutic market is also described.
Through the present study interesting results arise concerning the inclusion of biosimilars into
health systems and their contribution in reducing pharmaceutical costs. Presenting important parameters
that reinforce the prescription of biosimilars is accompanied by multiple challenges and therefore the
creation of a conststent policy framework defining their insertion in the pharmaceutic market is required.
Main subject category:
Health Sciences
Keywords:
Biosimilars, Biologics, Biosimilarity, Interchangeability, Biosimilars in oncology
Number of references:
132
