General characteristics of clinical trials for biosimilar drugs


AKICI A., Vizdiklar C.

MARMARA MEDICAL JOURNAL, vol.34, no.2, pp.89-94, 2021 (ESCI) identifier identifier

  • Publication Type: Article / Review
  • Volume: 34 Issue: 2
  • Publication Date: 2021
  • Doi Number: 10.5472/marumj.942752
  • Journal Name: MARMARA MEDICAL JOURNAL
  • Journal Indexes: Emerging Sources Citation Index (ESCI), Scopus, Academic Search Premier, CINAHL, EMBASE, TR DİZİN (ULAKBİM)
  • Page Numbers: pp.89-94
  • Marmara University Affiliated: Yes

Abstract

Biosimilar is a highly similar product to biological reference medicinal product. The development, licensing and clinical use of these products differ from the implementations of conventional drugs, which were shaped on the concept of equivalence, in various aspects. Negative attitudes towards generic drugs, many of which are thought to be based on lack of knowledge, are still substantial. There is concern that the problem may reach more critical levels in the use of biosimilars, which are known to he more complex compared to generics. Knowing the prominent critical aspects of the development process of the biosimilars may contribute to the solution of this problem that causes significant difficulties in practice.