Articles

Review Article

Published on 30 March 2022

Manufacture and regulation of cell, tissue and gene therapy products: global perspectives, challenges and next steps

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Christine Koh, BSc (Pharm) (Hon); Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD Abstract: Cell,...

cell, good manufacturing practice, quality control, regulatory framework, tissue and gene therapy products

DOI: 10.5639/gabij.2022.1102.012

14.142 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

7.993 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

2.800 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

3.366 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

1.256 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

3.189 views

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Opinion

Published on 17 December 2021

Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance

Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each...

Author(s): Pablo Matar, PhD

divergence, drift, evolution, interchangeability, pharmacovigilance, variability

DOI: 10.5639/gabij.2022.1101.006

4.535 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

5.219 views

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Review Article

Published on 28 February 2022

Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Adelia Pheh1, BSc (Pharm) (Hon); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm)...

challenges, COVID-19 vaccines, harmonization, manufacturing, regulation, traditional vaccines

DOI: 10.5639/gabij.2022.1101.004

9.738 views

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Review Article

Published on 28 January 2022

Biotherapeutic products in the European Pharmacopoeia: have all challenges been tackled?

Author byline as per print journal: Mihaela Buda, PhD; Olga Kolaj-Robin, PhD; Emmanuelle Charton, PhD Abstract: The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs in the field of...

biosimilars, biotherapeutics, monographs, pharmacopoeia, public standards

DOI: 10.5639/gabij.2022.1101.003

5.521 views

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Letters to the Editor

Published on 17 December 2021

No need for systematic switch studies to demonstrate interchangeability of biosimilars

Abstract: Systematic clinical switch studies to demonstrate interchangeability of biosimilars are required in some jurisdictions while theoretical considerations and current clinical data question the feasibility and relevance of such studies....

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

biosimilars, immunogenicity, interchangeability, switch studies

DOI: 10.5639/gabij.2022.1101.002

6.645 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

1.755 views

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