General characteristics of clinical trials for biosimilar drugs


AKICI A., Vizdiklar C.

MARMARA MEDICAL JOURNAL, cilt.34, sa.2, ss.89-94, 2021 (ESCI) identifier identifier

  • Yayın Türü: Makale / Derleme
  • Cilt numarası: 34 Sayı: 2
  • Basım Tarihi: 2021
  • Doi Numarası: 10.5472/marumj.942752
  • Dergi Adı: MARMARA MEDICAL JOURNAL
  • Derginin Tarandığı İndeksler: Emerging Sources Citation Index (ESCI), Scopus, Academic Search Premier, CINAHL, EMBASE, TR DİZİN (ULAKBİM)
  • Sayfa Sayıları: ss.89-94
  • Marmara Üniversitesi Adresli: Evet

Özet

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.