Articles

Published on 29 November 2022

2022/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2022, Issue 2 Commentary Substitution and interchangeability: time for a conversation? Original Research On statistical evaluation for interchangeability of...

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Thank you to reviewers

Published on 29 November 2022

Thank you to reviewers 2021

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 (GaBI...

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Original Research

Published on 24 November 2022

Pharmacokinetic bioequivalence of sitagliptin phosphate tablet formulations: a randomized, open-label, crossover study in healthy volunteers

Author byline as per print journal: Chuei Wuei Leong1, PhD; Elton Sagim1, BBiomedSc; Kar Ming Yee1, BPharm; Muhammad Shalhadi Saharuddin1, BSc; Nik Mohd Zulhakimi Nik Abdullah1, BSc; Noramirah Farhanah Saberi1,...

bioequivalence, new branded generics, pharmacokinetics, sitagliptin

DOI: 10.5639/gabij.2023.1201.003

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Review Article

Published on 26 September 2022

Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study

Abstract: This article describes the European Pharmacopoeia (Ph. Eur.) exploratory study on infliximab as a test case for developing public standards for monoclonal antibodies. The design and outcome of the...

Author(s): Mihaela Buda, PhD

flexibility, infliximab, monographs, pharmacopoeia, public standards, reference preparations

DOI: 10.5639/gabij.2022.1103.017

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Original Research

Published on 08 September 2022

Social trust and regional variation in the adoption of biosimilars in Italy and Germany

Introduction/Study Objectives: Adoption of biosimilars has fallen below projections, despite the vigorous implementation of economic incentives, thereby highlighting the importance of behavioural factors such as social trust. This paper analyses...

Author(s): Professor James C Robinson, PhD, MPH

biosimilars, Germany, healthcare costs, Italy, medicine prices, social trust

DOI: 10.5639/gabij.2022.1103.015

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Original Research

Published on 08 September 2022

US prescribers’ attitudes and perceptions about biosimilars

Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Introduction: In the United States (US), a legal framework for approving biosimilars was...

biosimilars, interchangeability, substitution, switching, US

DOI: 10.5639/gabij.2022.1103.016

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Editor's Letter

Published on 08 September 2022

What to look forward to in GaBI Journal, 2022, Issue 2

The rate of successful development, regulatory approval and marketing of both new and follow-on biological treatments has continued to accelerate despite, and in some cases because of, a seemingly endless...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1102.008

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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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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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Commentary

Published on 19 July 2022

Substitution and interchangeability: time for a conversation?

Author byline as per print journal: Chad Rieger1, MBA; Lisa Hall1, PhD; David Lim2,3, DPH Abstract: Bandiera et al. (2002) identified the potential for competitors’ promotional materials to use certain...

Australia, interchangeability, substitution

DOI: 10.5639/gabij.2022.1102.009

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Original Research

Published on 24 June 2022

A case study of AstraZeneca’s omeprazole/esomeprazole chiral switch strategy

Author byline as per print journal: Federico J Piñeiro, Pharm, MPH; Fernández Argüelles Rogelio Alberto, Pharm, PhD Introduction/Objective: To describe the chiral switch, an evergreening strategy used by AstraZeneca to position...

Author(s): Federico J Piñeiro, Pharm, MPH, Fernández Argüelles Rogelio Alberto, Pharm, PhD

AstraZeneca, Big Pharma, biosimilars, chiral switch, esomeprazol, generics

DOI: 10.5639/gabij.2022.1102.011

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