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 structure and function and has no clinically meaningful difference in terms of safety, purity or potency. Under the Biologics Price Competition and Innovation Act of…

biosimilars, interchangeability, logarithmic transformation, statistical evaluation

DOI: 10.5639/gabij.2022.1102.010

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 terms with technical meanings, such as ‘interchangeable’ and ‘substitution’, in a misleading way in Australia. Submitted: 30 June 2022; Revised: 4 July 2022; Accepted: 5…

Australia, interchangeability, substitution

DOI: 10.5639/gabij.2022.1102.009

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 enantiopure esomeprazole as the new proton pump inhibitor market leader, displacing its predecessor omeprazole. Methodology: A four-stage systematic review which included: a preliminary review, bibliographic…

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

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 resource-poor countries, both the pace and direction of changes are beginning to produce some encouraging signs. Positive trends are in part the result of the…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1101.001

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 Pharmacopoeia: have all challenges been tackled? Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines Long-acting insulin analogues. Drug selection by…

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 confidence in the data obtained from characterization studies? The expectation from regulatory authorities when assessing methods for product characterization is that there will be some…

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

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 sufficient knowledge of each individual insulin formulation and device. Reducing the number of different insulin analogues used, based on rational criteria, allows physicians and pharmacists…

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

DOI: 10.5639/gabij.2022.1101.005

Author(s): Jennifer Campbell

Author(s): Michael Cohan

Innovator drug sourcing challenges

Author(s): Christopher Gillespie, Jennifer Campbell, Michael Phillips

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, tissue and gene therapy products (CTGTPs) are therapeutic products intended for use in humans for prophylactic, diagnostic, curative, palliative or diagnostic purposes. Generally, they are…

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

DOI: 10.5639/gabij.2022.1102.012

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) (Hon), PhD Abstract: Since the onset of the COVID-19 pandemic, there has been a significant surge in interest of COVID-19 vaccines in particular, and other…

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

DOI: 10.5639/gabij.2022.1101.004