Cargando…

Does China’s competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine

With the National Centralized Drug Procurement policy gradually applied nationally in China, concerns about the effectiveness and safety of bid-winning generic drugs are growing again, but relevant studies are lacking. This real-world, before-and-after study was conducted to explore the clinical eff...

Descripción completa

Detalles Bibliográficos
Autores principales: Zhang, Chao, Ding, Yudan, Wu, Zhenzhen, Wang, Juan, Wu, Xiangping, Xie, Weiwei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9999380/
https://www.ncbi.nlm.nih.gov/pubmed/36909190
http://dx.doi.org/10.3389/fphar.2023.1097600
_version_ 1784903652233707520
author Zhang, Chao
Ding, Yudan
Wu, Zhenzhen
Wang, Juan
Wu, Xiangping
Xie, Weiwei
author_facet Zhang, Chao
Ding, Yudan
Wu, Zhenzhen
Wang, Juan
Wu, Xiangping
Xie, Weiwei
author_sort Zhang, Chao
collection PubMed
description With the National Centralized Drug Procurement policy gradually applied nationally in China, concerns about the effectiveness and safety of bid-winning generic drugs are growing again, but relevant studies are lacking. This real-world, before-and-after study was conducted to explore the clinical effects of switching between two versions of generic olanzapine (one of them was bid-winning product). Pre-and post-switching serum olanzapine concentrations were compared. A total of 30 patients were included and results showed the log-transformed, dose-adjusted concentration of bid-winning generic olanzapine was significantly lower than that of another generic olanzapine, while no significant differences were shown on Clinical Global Impressions Severity of Illness or Improvement ratings before and after switching. This study suggest that a generic version of a psychotropic medication may not be of therapeutic equivalence or bioequivalence with another generic one. Changes in efficacy or tolerability are possible in every switch. Therapeutic drug monitoring could be a valuable tool during switches between generic drugs. Larger prospective clinical studies for other generic psychotropic medications in target populations are warranted.
format Online
Article
Text
id pubmed-9999380
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-99993802023-03-11 Does China’s competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine Zhang, Chao Ding, Yudan Wu, Zhenzhen Wang, Juan Wu, Xiangping Xie, Weiwei Front Pharmacol Pharmacology With the National Centralized Drug Procurement policy gradually applied nationally in China, concerns about the effectiveness and safety of bid-winning generic drugs are growing again, but relevant studies are lacking. This real-world, before-and-after study was conducted to explore the clinical effects of switching between two versions of generic olanzapine (one of them was bid-winning product). Pre-and post-switching serum olanzapine concentrations were compared. A total of 30 patients were included and results showed the log-transformed, dose-adjusted concentration of bid-winning generic olanzapine was significantly lower than that of another generic olanzapine, while no significant differences were shown on Clinical Global Impressions Severity of Illness or Improvement ratings before and after switching. This study suggest that a generic version of a psychotropic medication may not be of therapeutic equivalence or bioequivalence with another generic one. Changes in efficacy or tolerability are possible in every switch. Therapeutic drug monitoring could be a valuable tool during switches between generic drugs. Larger prospective clinical studies for other generic psychotropic medications in target populations are warranted. Frontiers Media S.A. 2023-02-22 /pmc/articles/PMC9999380/ /pubmed/36909190 http://dx.doi.org/10.3389/fphar.2023.1097600 Text en Copyright © 2023 Zhang, Ding, Wu, Wang, Wu and Xie. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Zhang, Chao
Ding, Yudan
Wu, Zhenzhen
Wang, Juan
Wu, Xiangping
Xie, Weiwei
Does China’s competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine
title Does China’s competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine
title_full Does China’s competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine
title_fullStr Does China’s competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine
title_full_unstemmed Does China’s competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine
title_short Does China’s competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine
title_sort does china’s competitive generic substitution policy deliver equivalent clinical outcomes? a pilot study with two generic formulations of olanzepine
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9999380/
https://www.ncbi.nlm.nih.gov/pubmed/36909190
http://dx.doi.org/10.3389/fphar.2023.1097600
work_keys_str_mv AT zhangchao doeschinascompetitivegenericsubstitutionpolicydeliverequivalentclinicaloutcomesapilotstudywithtwogenericformulationsofolanzepine
AT dingyudan doeschinascompetitivegenericsubstitutionpolicydeliverequivalentclinicaloutcomesapilotstudywithtwogenericformulationsofolanzepine
AT wuzhenzhen doeschinascompetitivegenericsubstitutionpolicydeliverequivalentclinicaloutcomesapilotstudywithtwogenericformulationsofolanzepine
AT wangjuan doeschinascompetitivegenericsubstitutionpolicydeliverequivalentclinicaloutcomesapilotstudywithtwogenericformulationsofolanzepine
AT wuxiangping doeschinascompetitivegenericsubstitutionpolicydeliverequivalentclinicaloutcomesapilotstudywithtwogenericformulationsofolanzepine
AT xieweiwei doeschinascompetitivegenericsubstitutionpolicydeliverequivalentclinicaloutcomesapilotstudywithtwogenericformulationsofolanzepine