Articles

Published on 24 March 2020

2020/1 GaBI Journal Table of Contents

Contents Editor’s Letter Editor’s introduction to the initial issue of the ninth volume of GaBI Journal Original Research Stability of the trastuzumab biosimilar ABP 980 compared to reference product after...

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Published on 09 July 2020

2020/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2020, Issue 2 Commentary Importance of the determination of the higher order structure in the in-use stability studies of...

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Perspective

Published on 19 April 2024

Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort

Abstract: In principle, biosimilars could mitigate the problem of the rising cost of biological medicines. However, the current stringent and non-harmonized regulatory practices hinder competition and contribute to the high...

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

biosimilars, competition, controlled efficacy studies, harmonization

DOI: 10.5639/gabij.2024.1301.004

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Perspective

Published on 12 August 2024

US interchangeability designation: are we ready to cut the Gordian knot?

Author byline as per print journal: Joseph P Park1, PhD; Gillian R Woollett2, MA, DPhil Abstract: US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the...

Author(s): Gillian R Woollett, MA, DPhil, Joseph P Park, PhD

biosimilars, BPCIA, interchangeability, market exclusivity, quality, switching

DOI: 10.5639/gabij.2024.1303.035

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Thank you to reviewers

Published on 02 October 2019

Thank you to reviewers 2018

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal...

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Published on 02 December 2020

2020/4 GaBI Journal Table of Contents

Contents Editor’s Letter Medical journal publication during global stress Editorial Is the local tolerance of injectable biosimilars too underestimated? Commentary A white paper: US biosimilars market on pace with Europe...

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Editor's Letter

Published on 16 December 2021

Fourth and final issue of GaBI Journal’s 10th volume

This issue of the GaBI Journal contains only a limited number of articles, but these include two scientific very data-rich articles and an interesting and important expose on the use...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1004.020

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Published on 26 April 2022

2022/1 GaBI Journal Table of Contents

Contents Editor’s Letter First 2022 GaBI Journal issue highlights Letter to Editor No need for systematic switch studies to demonstrate interchangeability of biosimilars Review Article Biotherapeutic products in the European...

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Editor's Letter

Published on 26 April 2022

First 2022 GaBI Journal issue highlights

The first GaBI Journal issue of 2022 comes at a time of both hope and despair. While the COVID-19 pandemic continues to cause significant global morbidity and mortality; especially in...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1101.001

1.755 views

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Published on 09 March 2021

2021/1 GaBI Journal Table of Contents

Contents Editor’s Letter First 2021 GaBI Journal issue highlights Original Research Biosimilars – status in July 2020 in 16 countries An assessment of trends in the Iranian pharmaceutical market following...

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Sponsored Article

Published on 19 August 2022

Front-loading biosimilar development with analytical characterization

Abstract: An online roundtable discussion entitled ‘Front-loading biosimilar development with analytical characterization’ was hosted by BioPharmaSpec. The panellists discussed different regulatory approaches to the clinical trials needed for approval and...

Author(s): Richard L Easton, BSC (Hons), DIC, PhD

analytics, biosimilars, functional testing, orthogonality, structural characterization

DOI: 10.5639/gabij.2022.1102.013

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Published on 22 June 2021

2021/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2021, Issue 2 Original Research Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation Biosimilars in Saudi...

1.622 views

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