Articles

Published on 07 July 2016

2016/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2016, Issue 2 Editorial Adjusted indirect comparisons between generics – bioequivalence and interchangeability Review Article Assessment of the interchangeability...

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Original Research

Published on 01 August 2022

On statistical evaluation for interchangeability of biosimilar products

Author byline as per print journal: Yuqi Li, BS Pharm; Shein-Chung Chow, PhD Abstract:  A biosimilar product is a biological product which is highly similar to an existing reference product in...

biosimilars, interchangeability, logarithmic transformation, statistical evaluation

DOI: 10.5639/gabij.2022.1102.010

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Published on 08 June 2016

2016/1 GaBI Journal Table of Contents

Contents Editor’s Letter Editor’s introduction to the initial issue of the fifth volume of GaBI Journal Letters to the Editor First biosimilar of infliximab approved in Brazil: response from the...

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Editor's Letter

Published on 03 December 2018

Latest features in GaBI Journal, 2018, Issue 3

This third issue of GaBI Journal in 2018 contains manuscripts which discuss a number of important, post-marketing, ‘real world’ generic and biosimilar medicinal product issues. In a Commentary, Pitts and...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0703.020

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Editor's Letter

Published on 28 January 2019

Fourth and final issue of GaBI Journal’s seventh volume

Globalization of the world’s economy has clearly created both major advances and ongoing challenges including in the pharmaceutical industry. Naming of pharmaceuticals might seem to be an uninteresting topic to...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0704.028

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Editor's Letter

Published on 12 June 2017

What to look forward to in GaBI Journal, 2017, Issue 2

The use both generics and biosimilars offers the potential to increase availability of medicines through decreases in cost that should occur when an expensive product (drug) loses patent protection and...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0602.011

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Editor's Letter

Published on 23 February 2021

First 2021 GaBI Journal issue highlights

The articles in this first issue contain a large volume of useful information on the global development, approval, manufacturing, marketing, and uptake of biosimilars. The first Original Research by Dr...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1001.001

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Published on 24 April 2017

2017/1 GaBI Journal Table of Contents

Contents Editor’s Letter Editor’s introduction to the initial issue of the sixth volume of GaBI Journal Letters to the Editor Pricing strategies for pharmaceuticals in developing countries: what options do...

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Editor's Letter

Published on 29 May 2019

Editor’s introduction to the initial issue of the eighth volume of GaBI Journal

This issue contains important information and manuscripts, but the small number of original papers illustrates the challenge the GaBI Journal (as well as many other legitimate journals) is having attracting...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2019.0801.001

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Published on 05 January 2018

2018/1 GaBI Journal Table of Contents

Contents Editor’s Letter Editor’s introduction to the initial issue of the seventh volume of GaBI Journal Commentary EU Member States have tools to reduce costs of bestseller biologicals but can...

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Perspective

Published on 21 August 2024

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

Abstract:US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the legal designation was first created in 2010. Based on experience, FDA now acknowledges that clinical switching...

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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Published on 05 September 2018

2018/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2018, Issue 2 Commentary Potential changes to the FDA approach to biosimilars have a global impact Original Research Patient-reported...

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