Pub Date : 2018-06-15DOI: 10.5639/GABIJ.2018.0702.018
Sarfaraz K Niazi
{"title":"Rationalizing FDA guidance on biosimilars — expediting approvals and acceptance","authors":"Sarfaraz K Niazi","doi":"10.5639/GABIJ.2018.0702.018","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0702.018","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87439127","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 : 2018-06-15DOI: 10.5639/GABIJ.2018.0702.013
R. Jefferis
{"title":"Protein heterogeneity and the immunogenicity of biotherapeutics","authors":"R. Jefferis","doi":"10.5639/GABIJ.2018.0702.013","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0702.013","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83008267","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 : 2018-03-15DOI: 10.5639/GABIJ.2018.0701.002
P. Kurki
{"title":"EU Member States have tools to reduce costs of bestseller biologicals but can they use them","authors":"P. Kurki","doi":"10.5639/GABIJ.2018.0701.002","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0701.002","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82180112","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 : 2018-03-15DOI: 10.5639/GABIJ.2018.0701.003
Maki Matsuhama, Ryosuke Kuribayashi
{"title":"Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients","authors":"Maki Matsuhama, Ryosuke Kuribayashi","doi":"10.5639/GABIJ.2018.0701.003","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0701.003","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72447638","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 : 2018-03-15DOI: 10.5639/GABIJ.2018.0701.005
Hajaj M Alhomaidan, Ali M Alhomaidan
{"title":"The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US","authors":"Hajaj M Alhomaidan, Ali M Alhomaidan","doi":"10.5639/GABIJ.2018.0701.005","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0701.005","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91103994","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 : 2018-03-15DOI: 10.5639/GABIJ.2018.0701.006
J. A. Cortes, Francisco Javier Saura Esteban
{"title":"Regulations for biotherapeutics approval in Colombia","authors":"J. A. Cortes, Francisco Javier Saura Esteban","doi":"10.5639/GABIJ.2018.0701.006","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0701.006","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82298004","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 : 2018-02-27DOI: 10.5639/GABIJ.2018.0701.004
G. O’Brien, D. Carrol, Mark Mulcahy, V. Walshe, G. Courtney, S. Byrne
{"title":"Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence","authors":"G. O’Brien, D. Carrol, Mark Mulcahy, V. Walshe, G. Courtney, S. Byrne","doi":"10.5639/GABIJ.2018.0701.004","DOIUrl":"https://doi.org/10.5639/GABIJ.2018.0701.004","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77550397","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 : 2017-12-15DOI: 10.5639/gabij.2017.0604.035
Michael Sarshad
{"title":"Major lessons learned from Zarxio’s US launch: the start of a biosimilar revolution","authors":"Michael Sarshad","doi":"10.5639/gabij.2017.0604.035","DOIUrl":"https://doi.org/10.5639/gabij.2017.0604.035","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84403334","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 : 2017-12-15DOI: 10.5639/GABIJ.2017.0604.034
H. Larkin, J. Macdonald, Rebecca S Lumsden
{"title":"Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution policies","authors":"H. Larkin, J. Macdonald, Rebecca S Lumsden","doi":"10.5639/GABIJ.2017.0604.034","DOIUrl":"https://doi.org/10.5639/GABIJ.2017.0604.034","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81582886","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 : 2017-12-15DOI: 10.5639/gabij.2017.0604.032
K. Bodhinathan
{"title":"Comment on the non-biological complex drugs paper","authors":"K. Bodhinathan","doi":"10.5639/gabij.2017.0604.032","DOIUrl":"https://doi.org/10.5639/gabij.2017.0604.032","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85824928","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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