Pub Date : 2019-06-15DOI: 10.5639/gabij.2019.0802.008
G. Castañeda-Hernández, L. Carbajal-Rodríguez, M. Cerón-Rodríguez, LC Correa González, A. Esquivel-Aguilar, Sj Franco-Ornelas, JE García Ortiz, CM Hernández Guadarrama, J. I. Navarrete-Martínez, Y. Santillán-Hernández, E. Terreros-Muñoz
{"title":"Are there biosimilar orphan drugs for Gaucher disease? An overview in Mexico","authors":"G. Castañeda-Hernández, L. Carbajal-Rodríguez, M. Cerón-Rodríguez, LC Correa González, A. Esquivel-Aguilar, Sj Franco-Ornelas, JE García Ortiz, CM Hernández Guadarrama, J. I. Navarrete-Martínez, Y. Santillán-Hernández, E. Terreros-Muñoz","doi":"10.5639/gabij.2019.0802.008","DOIUrl":"https://doi.org/10.5639/gabij.2019.0802.008","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76566744","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}
Pub Date : 2019-06-15DOI: 10.5639/GABIJ.2019.0802.007
B. Godman, A. Hill, S. Simoens, A. Kurdi, J. Gulbinovič, A. Martin, A. Timoney, D. Gotham, J. Wale, T. Bochenek, Celia C. Rothe, Iris Hoxha, Admir Malaj, Christian Hierländer, R. Sauermann, W. Hamelinck, Z. Mitkova, G. Petrova, O. Laius, C. Sermet, I. Langer, G. Selke, J. Yfantopoulos, R. Joppi, A. Jakupi, E. Poplavska, Ieva Greičiūtė-Kuprijanov, P. V. Bonanno, J. Piepenbrink, V. D. Valk, C. Hagen, A. Ringerud, R. Plisko, M. Władysiuk, Vanda Marković-Peković, N. Grubiša, I. Mardare, T. Novakovic, Tatjana Ponorac, M. Parker, Jurij Fürst, Dominic Tomek, M. Cortadellas, Corrine Zara, Maria Juhasz-Haverinen, Peter Skiold, S. McTaggart, A. Haycox
Introduction: There are appreciable concerns among European health authorities with growing expenditure on cancer medicines and issues of sustainability. The enhanced use of low cost generics could help. Aims: Consequently, there is a need to comprehensively document current and future arrangements regarding the pricing of generic cancer medicines across Europe, and whether these are indication specific, as well as how this translates into actual prices to provide future direction. Methodology: Mixed method approach with qualitative research among senior health authority personnel and their advisers. Quantitative research via health authority databases to ascertain current prices for oral cancer medicines that had lost their patent and the influence of population size and economics on prices. Results: 25 European countries participated. Currently we see (a) variable approaches to the pricing of generic cancer medicines, which will continue; (b) no concerns with substitution for oral generic cancer medicines; (c) substantial price reductions versus originators for generic capecitabine (up to -93.1%), generic imatinib (up to -97.8%) and generic temozolomide (up to -80.7%). Prices for oncology medicines are not indication specific, and are not affected by population size although influenced by pricing approaches. There have also been price increases for some non-patented cancer medicines following manufacturer changes although now stabilising. Conclusion: The considerable price reductions seen for some generics means health authorities should further encourage the use of generic oncology medicines when they become available to fund increased volumes and new valued cancer medicines. Countries are also starting to address price increases for generics following changes in the manufacturer
{"title":"Pricing of oral generic cancer medicines in 25 European countries; findings and implications","authors":"B. Godman, A. Hill, S. Simoens, A. Kurdi, J. Gulbinovič, A. Martin, A. Timoney, D. Gotham, J. Wale, T. Bochenek, Celia C. Rothe, Iris Hoxha, Admir Malaj, Christian Hierländer, R. Sauermann, W. Hamelinck, Z. Mitkova, G. Petrova, O. Laius, C. Sermet, I. Langer, G. Selke, J. Yfantopoulos, R. Joppi, A. Jakupi, E. Poplavska, Ieva Greičiūtė-Kuprijanov, P. V. Bonanno, J. Piepenbrink, V. D. Valk, C. Hagen, A. Ringerud, R. Plisko, M. Władysiuk, Vanda Marković-Peković, N. Grubiša, I. Mardare, T. Novakovic, Tatjana Ponorac, M. Parker, Jurij Fürst, Dominic Tomek, M. Cortadellas, Corrine Zara, Maria Juhasz-Haverinen, Peter Skiold, S. McTaggart, A. Haycox","doi":"10.5639/GABIJ.2019.0802.007","DOIUrl":"https://doi.org/10.5639/GABIJ.2019.0802.007","url":null,"abstract":"Introduction: There are appreciable concerns among European health authorities with growing expenditure on cancer medicines and issues of sustainability. The enhanced use of low cost generics could help. Aims: Consequently, there is a need to comprehensively document current and future arrangements regarding the pricing of generic cancer medicines across Europe, and whether these are indication specific, as well as how this translates into actual prices to provide future direction. Methodology: Mixed method approach with qualitative research among senior health authority personnel and their advisers. Quantitative research via health authority databases to ascertain current prices for oral cancer medicines that had lost their patent and the influence of population size and economics on prices. Results: 25 European countries participated. Currently we see (a) variable approaches to the pricing of generic cancer medicines, which will continue; (b) no concerns with substitution for oral generic cancer medicines; (c) substantial price reductions versus originators for generic capecitabine (up to -93.1%), generic imatinib (up to -97.8%) and generic temozolomide (up to -80.7%). Prices for oncology medicines are not indication specific, and are not affected by population size although influenced by pricing approaches. There have also been price increases for some non-patented cancer medicines following manufacturer changes although now stabilising. Conclusion: The considerable price reductions seen for some generics means health authorities should further encourage the use of generic oncology medicines when they become available to fund increased volumes and new valued cancer medicines. Countries are also starting to address price increases for generics following changes in the manufacturer","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77318825","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}
Pub Date : 2019-06-15DOI: 10.5639/gabij.2019.0802.006
P. Walson
{"title":"Unmet potential of Generics and Biosimilars to reduce healthcare costs","authors":"P. Walson","doi":"10.5639/gabij.2019.0802.006","DOIUrl":"https://doi.org/10.5639/gabij.2019.0802.006","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79623926","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}
Pub Date : 2019-03-15DOI: 10.5639/gabij.2019.0801.001
P. Walson
{"title":"Editor’s introduction to the initial issue of the eighth volume of GaBI Journal","authors":"P. Walson","doi":"10.5639/gabij.2019.0801.001","DOIUrl":"https://doi.org/10.5639/gabij.2019.0801.001","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81159505","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}
Pub Date : 2019-03-15DOI: 10.5639/gabij.2019.0801.002
Enrico Adriano Raffaelli, Fausto Massimino
{"title":"Biosimilars: considerations in light of the Italian legal framework","authors":"Enrico Adriano Raffaelli, Fausto Massimino","doi":"10.5639/gabij.2019.0801.002","DOIUrl":"https://doi.org/10.5639/gabij.2019.0801.002","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91246322","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}
Pub Date : 2019-03-15DOI: 10.5639/gabij.2019.0801.005
GaBI Journal Editor
{"title":"Regulatory requirements for the acceptance of foreign comparator products in the participants of the International Generic Drug Regulators Programme","authors":"GaBI Journal Editor","doi":"10.5639/gabij.2019.0801.005","DOIUrl":"https://doi.org/10.5639/gabij.2019.0801.005","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72482456","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}
Pub Date : 2019-03-15DOI: 10.5639/gabij.2019.0801.004
GaBI Journal Editor
{"title":"Top developments in biosimilars during 2018","authors":"GaBI Journal Editor","doi":"10.5639/gabij.2019.0801.004","DOIUrl":"https://doi.org/10.5639/gabij.2019.0801.004","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79334986","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}
Pub Date : 2018-12-15DOI: 10.5639/gabij.2018.0704.029
R. Thorpe
{"title":"Nomenclature for biosimilars; a continuing thorny issue","authors":"R. Thorpe","doi":"10.5639/gabij.2018.0704.029","DOIUrl":"https://doi.org/10.5639/gabij.2018.0704.029","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72989691","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}
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