{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T17:15:13Z","timestamp":1792084513906,"version":"4.4.0"},"reference-count":17,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,2,22]],"date-time":"2023-02-22T00:00:00Z","timestamp":1677024000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.3389\/fphar.2023.1097600","type":"journal-article","created":{"date-parts":[[2023,2,22]],"date-time":"2023-02-22T08:02:56Z","timestamp":1677052976000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["Does China\u2019s competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine"],"prefix":"10.3389","volume":"14","author":[{"given":"Chao","family":"Zhang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yudan","family":"Ding","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenzhen","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangping","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weiwei","family":"Xie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,2,22]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1080\/13651501.2018.1508724","article-title":"Switching medication products during the treatment of psychiatric illness","volume":"23","author":"Blier","year":"2019","journal-title":"Int. J. psychiatry Clin. Pract."},{"key":"B2","doi-asserted-by":"publisher","first-page":"1578","DOI":"10.1016\/s0149-2918(03)80157-1","article-title":"The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs","volume":"25","author":"Borgheini","year":"2003","journal-title":"Clin. Ther."},{"key":"B3","doi-asserted-by":"publisher","first-page":"353","DOI":"10.1007\/s40263-013-0045-2","article-title":"Rational use of generic psychotropic drugs","volume":"27","author":"Carbon","year":"2013","journal-title":"CNS Drugs"},{"key":"B4","doi-asserted-by":"publisher","first-page":"195","DOI":"10.1055\/s-0031-1286287","article-title":"AGNP consensus guidelines for therapeutic drug monitoring in psychiatry: Update 2011","volume":"44","author":"Hiemke","year":"2011","journal-title":"Pharmacopsychiatry"},{"key":"B5","doi-asserted-by":"publisher","first-page":"827","DOI":"10.1097\/FTD.0000000000000211","article-title":"Generic olanzapine substitution in patients with schizophrenia: Assessment of serum concentrations and therapeutic response after switching","volume":"37","author":"Italiano","year":"2015","journal-title":"Ther. drug Monit."},{"key":"B6","doi-asserted-by":"publisher","first-page":"100","DOI":"10.1016\/j.jchromb.2006.05.031","article-title":"Quantitative determination of forty-eight antidepressants and antipsychotics in human serum by HPLC tandem mass spectrometry: A multi-level, single-sample approach","volume":"843","author":"Kirchherr","year":"2006","journal-title":"J. Chromatogr. B, Anal. Technol. Biomed. life Sci."},{"key":"B7","doi-asserted-by":"publisher","first-page":"94","DOI":"10.1071\/hc15094","article-title":"The impact on health outcome measures of switching to generic medicines consequent to reference pricing: The case of olanzapine in New Zealand","volume":"7","author":"Lessing","year":"2015","journal-title":"J. Prim. Health Care"},{"key":"B8","first-page":"1164","article-title":"Analysis and discussion of generic drug consistency evaluation in NMPA and relevant drug policies in FDA and PMDA","volume":"30","author":"Li","year":"2021","journal-title":"Chin. J. New Drugs"},{"key":"B9","doi-asserted-by":"publisher","first-page":"63","DOI":"10.2147\/CEOR.S17846","article-title":"Adherence and persistence with branded antidepressants and generic SSRIs among managed care patients with major depressive disorder","volume":"3","author":"Liu","year":"2011","journal-title":"Clin. Outcomes Res."},{"key":"B10","doi-asserted-by":"publisher","first-page":"769","DOI":"10.2165\/00023210-200418120-00002","article-title":"The generic alternative in schizophrenia: Opportunity or threat?","volume":"18","author":"Nuss","year":"2004","journal-title":"CNS Drugs"},{"key":"B11","unstructured":"Health at a glance: Asia\/pacific 20122012"},{"key":"B12","doi-asserted-by":"publisher","first-page":"281","DOI":"10.1007\/s40261-015-0374-7","article-title":"Interchangeability, safety and efficacy of modified-release drug formulations in the USA: The case of opioid and other nervous system drugs","volume":"36","author":"Seoane-Vazquez","year":"2016","journal-title":"Clin. Drug Investig."},{"key":"B13","doi-asserted-by":"publisher","first-page":"257","DOI":"10.1057\/palgrave.jgm.4940128","article-title":"Sustaining generic medicines markets in europe","volume":"3","author":"Simoens","year":"2006","journal-title":"J. Generic Med."},{"key":"B14","doi-asserted-by":"publisher","first-page":"e278","DOI":"10.1097\/MJT.0000000000000282","article-title":"Potential clinical and economic impact of switching branded medications to generics","volume":"24","author":"Straka","year":"2017","journal-title":"Am. J. Ther."},{"key":"B15","doi-asserted-by":"publisher","first-page":"1883","DOI":"10.1186\/s12889-021-11882-7","article-title":"Influence of Chinese national centralized drug procurement on the price of policy-related drugs: An interrupted time series analysis","volume":"21","author":"Wang","year":"2021","journal-title":"BMC Public Health"},{"key":"B16","doi-asserted-by":"publisher","first-page":"43","DOI":"10.3969\/j.issn.1672-3384.2022.06.008","article-title":"Efficacy and safety evaluation of selected drugs in the national volume-based procurement: A real-world study","volume":"20","author":"Yue","year":"2022","journal-title":"Clin. Medicat. J."},{"key":"B17","doi-asserted-by":"publisher","first-page":"5","DOI":"10.7664\/CHE20200601","article-title":"The results and analysis of national health accounts in China in 2018","volume":"39","author":"Zhai","year":"2020","journal-title":"Chin. Health Econoimcs"}],"container-title":["Frontiers in Pharmacology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2023.1097600\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,2,24]],"date-time":"2023-02-24T11:27:42Z","timestamp":1677238062000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2023.1097600\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,22]]},"references-count":17,"alternative-id":["10.3389\/fphar.2023.1097600"],"URL":"https:\/\/doi.org\/10.3389\/fphar.2023.1097600","relation":{},"ISSN":["1663-9812"],"issn-type":[{"value":"1663-9812","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,22]]},"article-number":"1097600"}}