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...

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Main Authors: Chao Zhang (Author), Yudan Ding (Author), Zhenzhen Wu (Author), Juan Wang (Author), Xiangping Wu (Author), Weiwei Xie (Author)
Format: Book
Published: Frontiers Media S.A., 2023-02-01T00:00:00Z.
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100 1 0 |a Chao Zhang  |e author 
700 1 0 |a Yudan Ding  |e author 
700 1 0 |a Zhenzhen Wu  |e author 
700 1 0 |a Juan Wang  |e author 
700 1 0 |a Xiangping Wu  |e author 
700 1 0 |a Weiwei Xie  |e author 
245 0 0 |a Does China's competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine 
260 |b Frontiers Media S.A.,   |c 2023-02-01T00:00:00Z. 
500 |a 1663-9812 
500 |a 10.3389/fphar.2023.1097600 
520 |a 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. 
546 |a EN 
690 |a generic olanzapine 
690 |a volumed-based drug procurement policy 
690 |a serum concentration 
690 |a clinical effect 
690 |a safety 
690 |a Therapeutics. Pharmacology 
690 |a RM1-950 
655 7 |a article  |2 local 
786 0 |n Frontiers in Pharmacology, Vol 14 (2023) 
787 0 |n https://www.frontiersin.org/articles/10.3389/fphar.2023.1097600/full 
787 0 |n https://doaj.org/toc/1663-9812 
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