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The need for distinct nomenclature for originator and biosimilar products 原料药和生物仿制药的不同命名的需要
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-12-15 DOI: 10.5639/gabij.2018.0704.031
Michael Sarshad, R. Campbell, Peter J. Pitts, Jacqueline Vanderpuye Orgle
{"title":"The need for distinct nomenclature for originator and biosimilar products","authors":"Michael Sarshad, R. Campbell, Peter J. Pitts, Jacqueline Vanderpuye Orgle","doi":"10.5639/gabij.2018.0704.031","DOIUrl":"https://doi.org/10.5639/gabij.2018.0704.031","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80926515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
First GCC stakeholder meeting on approval process, interchangeability/substitution and safety of biosimilars 2017 – Report 首次GCC利益相关方会议，讨论2017年生物仿制药的批准流程、可互换性/替代性和安全性
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-12-15 DOI: 10.5639/gabij.2018.0704.032
Gianluca Trifi rò, Meteb Al-Foheidi, Ali M Alhomaidan, A. Al-jedai, Musaed Alkholief, Mohammad Alsenaidy, A. Alshamsan, T. Kvien
{"title":"First GCC stakeholder meeting on approval process, interchangeability/substitution and safety of biosimilars 2017 – Report","authors":"Gianluca Trifi rò, Meteb Al-Foheidi, Ali M Alhomaidan, A. Al-jedai, Musaed Alkholief, Mohammad Alsenaidy, A. Alshamsan, T. Kvien","doi":"10.5639/gabij.2018.0704.032","DOIUrl":"https://doi.org/10.5639/gabij.2018.0704.032","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"67 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86544803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
US generic prescription drug markets 2004–2016 2004-2016年美国非专利处方药市场
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-12-15 DOI: 10.5639/gabij.2018.0704.033
GaBI Journal Editor
{"title":"US generic prescription drug markets 2004–2016","authors":"GaBI Journal Editor","doi":"10.5639/gabij.2018.0704.033","DOIUrl":"https://doi.org/10.5639/gabij.2018.0704.033","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"259 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75104191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ongoing activities to influence the prescribing of proton pump inhibitors within the Scottish National Health Service: their effect and implications 正在进行的活动，以影响处方质子泵抑制剂在苏格兰国家卫生服务:他们的影响和影响
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-11-12 DOI: 10.5639/GABIJ.2018.0704.030
B. Godman, A. Kurdi, H. McCabe, S. MacBride-Stewart, Axel Leporowski, S. Hurding, M. Bennie, A. Morton
{"title":"Ongoing activities to influence the prescribing of proton pump inhibitors within the Scottish National Health Service: their effect and implications","authors":"B. Godman, A. Kurdi, H. McCabe, S. MacBride-Stewart, Axel Leporowski, S. Hurding, M. Bennie, A. Morton","doi":"10.5639/GABIJ.2018.0704.030","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0704.030","url":null,"abstract":"Introduction: There has been a considerable increase in the use of proton pump inhibitors (PPIs) in recent years due to their effectiveness versus H2 antagonists. This includes reducing GI bleeds in patients at risk. However, there are concerns with their long term use and potential costs. Costs can be reduced with increased prescribing of low cost generic PPIs. Aims: To analyse the influence of multiple demand-side measures in Scotland in recent years to increase the prescribing of low cost generic PPIs as well as encourage the prescribing of lower strength PPIs. Methods: Documenting utilization (mainly items dispensed) and expenditure in Scotland from 2001 to 2017 using health authority databases combined with documenting the multiple initiatives and measures both nationally and regionally. Results: The multiple measures in Scotland ensured high International non-proprietary name prescribing (up to 100% for some PPIs) as well as the prescribing of generic versus patented PPIs, with costs of generic PPIs as low as 8.5% of their pre-patent loss prices. Overall, total expenditure on PPIs in Scotland was 66.7% lower in 2017 at GB£18.83million compared to 2001 levels. This was despite a 3.06-fold increase in PPI utilization during this period. The savings were driven by the increasing use of generic omeprazole and lansoprazole versus patent protected PPIs. There was also a reduction in the prescribing of high strength PPIs during this period. Conclusion: Multiple initiatives in Scotland in recent years have reduced expenditure on PPIs despite appreciably increased utilisation. Multiple initiatives have also helped to reduce the prescribing of higher strength PPIs. This is an exemplar to other countries seeking to enhance their prescribing efficiency","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"48 1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87688348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 16
Implementing a treatment registry for a biosimilar: continuous safety surveillance of the biosimilar Bevax® (bevacizumab) in Argentina 实施生物仿制药治疗注册:Bevax®(贝伐单抗)生物仿制药在阿根廷的持续安全监测
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-09-15 DOI: 10.5639/GABIJ.2018.0703.023
F. Fernández, Matías Deprati, Patricia Rodríguez Acedo, E. Spitzer, Á. Romera, N. Español
{"title":"Implementing a treatment registry for a biosimilar: continuous safety surveillance of the biosimilar Bevax® (bevacizumab) in Argentina","authors":"F. Fernández, Matías Deprati, Patricia Rodríguez Acedo, E. Spitzer, Á. Romera, N. Español","doi":"10.5639/GABIJ.2018.0703.023","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0703.023","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81654011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Latest features in GaBI Journal, 2018, Issue 3 《GaBI杂志》2018年第3期最新报道
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-09-15 DOI: 10.5639/gabij.2018.0703.020
P. Walson
{"title":"Latest features in GaBI Journal, 2018, Issue 3","authors":"P. Walson","doi":"10.5639/gabij.2018.0703.020","DOIUrl":"https://doi.org/10.5639/gabij.2018.0703.020","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"23 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86946331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
EU risk-sharing agreements between 2000−2015 2000 - 2015年欧盟风险分担协议
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-09-15 DOI: 10.5639/gabij.2018.0703.026
GaBI Journal Editor
{"title":"EU risk-sharing agreements between 2000−2015","authors":"GaBI Journal Editor","doi":"10.5639/gabij.2018.0703.026","DOIUrl":"https://doi.org/10.5639/gabij.2018.0703.026","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"37 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75494476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
How does generic drug policy affect market prices? 非专利药政策如何影响市场价格?
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-09-15 DOI: 10.5639/gabij.2018.0703.027
GaBI Journal Editor
{"title":"How does generic drug policy affect market prices?","authors":"GaBI Journal Editor","doi":"10.5639/gabij.2018.0703.027","DOIUrl":"https://doi.org/10.5639/gabij.2018.0703.027","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"43 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86598569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
First ASEAN educational workshop on regulation and approval of biosimilars/similar biotherapeutic products 2017 – Report 2017年首届东盟生物类似药/类似生物治疗产品监管和批准教育研讨会-报告
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-09-15 DOI: 10.5639/gabij.2018.0703.025
R. Thorpe, E. Griffiths, N. Ekman
{"title":"First ASEAN educational workshop on regulation and approval of biosimilars/similar biotherapeutic products 2017 – Report","authors":"R. Thorpe, E. Griffiths, N. Ekman","doi":"10.5639/gabij.2018.0703.025","DOIUrl":"https://doi.org/10.5639/gabij.2018.0703.025","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"51 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76562406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Medicines regulation in the MENA region and the importance of the World Health Organization’s INN proposal of Biological Qualifier 中东和北非地区的药品监管和世界卫生组织国际药品监管协会提出的生物限定条件的重要性
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2018-09-15 DOI: 10.5639/GABIJ.2018.0703.021
Peter J. Pitts, M. Reilly
{"title":"Medicines regulation in the MENA region and the importance of the World Health Organization’s INN proposal of Biological Qualifier","authors":"Peter J. Pitts, M. Reilly","doi":"10.5639/GABIJ.2018.0703.021","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0703.021","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"59 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78777696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
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