Biohasonló inzulinok a láthatáron

György Jermendy, Sándor Kerpel-Fronius

Research output: Article

Abstract

Nowadays human insulins and insulin analogues are exclusively used in the clinical practice, when insulin therapy is needed. The patents of human insulins are expired and will expire soon for glargine, the first long-acting, basal insulin analogue preparation. The reliable production of biosimilar insulins is a new challenge for the pharmaceutical industry. Independently developed insulins with appreciable clinical efficacy have already become available in some countries where the quality criteria of regulatory process in place are less strict than in the European Union. The first approval for true biosimilar insulin, i.e. for biosimilar glargine was given in Europe in 2014. In this article, the characteristics of biosimilar insulins, especially the difficulties in the manufacturing process are reviewed in comparison with generic drugs. It is of note that potential efficacy and safety differences may occur due to even minor changes in the production, formulation and storage of the biological drugs. Therefore, biosimilarity should be investigated by detailed comparative pharmacokinetic and pharmacodynamic studies. Moreover, similar clinical efficacy and safety should be documented by randomized, comparative clinical trials. The potential impact of altered immunologic profile of biosimilar insulins should also be carefully monitored.

Translated title of the contributionBiosimilar insulins on the horizon
Original languageHungarian
Pages (from-to)107-113
Number of pages7
JournalLege Artis Medicinae
Volume25
Issue number3
Publication statusPublished - jan. 1 2015

Keywords

  • Biosimilar glargine
  • Biosimilar insulin
  • Diabetes mellitus
  • Glargine
  • Insulin analogues
  • Insulin therapy

ASJC Scopus subject areas

  • Medicine(all)

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  • Cite this

    Jermendy, G., & Kerpel-Fronius, S. (2015). Biohasonló inzulinok a láthatáron. Lege Artis Medicinae, 25(3), 107-113.