Articles

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

4.999 views

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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

4.230 views

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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

1.282 views

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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

1.734 views

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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

2.871 views

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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

3.474 views

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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

9.560 views

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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

1.777 views

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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...

1.794 views

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Sponsored Article

Published on 25 April 2022

Structural characterization methods for biosimilars: fit-for-purpose, qualified or validated

Abstract: Detailed and accurate structural characterization of biopharmaceuticals is of paramount importance for product definition, assessment of impurities and achieving in-depth understanding of manufacturing processes. But how can we have...

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

analytical development, mass spectrometry, process related impurities, structural characterization

DOI: 10.5639/gabij.2022.1101.007

3.518 views

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Review Article

Published on 07 April 2022

Long-acting insulin analogues. Drug selection by means of the System of Objectified Judgement Analysis (SOJA)

Author byline as per print journal: Robert Janknegt, PharmD, PhD; Marloes Dankers, MSc Study objectives: The increasing number of long-acting insulin analogues makes it difficult for general practitioners to have...

degludec, detemir, diabetes mellitus, glargine, long-acting insulin analogues, NPH insulin

DOI: 10.5639/gabij.2022.1101.005

5.351 views

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