publication . Article . 2019

Comparative Studies of Biosimilar Medicinal Products

Talibov, O. B.;
Open Access Russian
  • Published: 05 Jun 2019 Journal: Ведомости Научного центра экспертизы средств медицинского применения, volume 9, issue 2, pages 93-100 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
Abstract
The article describes specific aspects of biosimilars research and development. The aim of the study was to analyse the ways to conduct comparative studies of biotechnological medicinal products and the main approaches to the assessment of the obtained data. The paper highlights that biotechnological products are associated with a much higher potential variability of chemical and pharmacological characteristics than small molecules. The author analyses the reasons of this phenomenon, describes mechanisms underlying the microheterogeneity of protein molecules, primarily post-translational modification. The latter has an impact on the pharmacokinetic parameters, p...
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Subjects
free text keywords: biotechnological medicinal products, monoclonal antibodies, biosimilars, microheterogeneity, post-translational modification, pharmacokinetics, pharmacodynamics, clinical trials, Medicine (General), R5-920, Biochemical engineering, Protein molecules, Complex protein, Computer science, Therapeutic equivalence, Posttranslational modification, Bioequivalence, Biosimilar
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