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 established via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). At the time of writing (September 2022), 38 biosimilars have been approved…

biosimilars, interchangeability, substitution, switching, US

DOI: 10.5639/gabij.2022.1103.016

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 biosimilar adoption across provinces in Italy and Germany, which evince strong variation in social trust, and across nations in Europe. Methods: Data for 2020 biosimilar…

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

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

DOI: 10.5639/gabij.2022.1103.015

Editor's Letter

Published on 29 December 2022

The importance of trust

It seems as if the entire world is dealing with a lack of trust, even in many things that have enriched and sustained human development, including our neighbours, teachers, the press, corporations, politicians, religious leaders, scientists, academic institutions, governments, and even the basic concepts of democracy. Lack of trust is posing a direct threat to…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1103.014

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 how this can affect structural and functional characterization; the best way to ‘front-load’ characterization Submitted: 18 June 2022 Revised: 19 July 2022; Accepted: 20 July…

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

analytics, biosimilars, functional testing, orthogonality, structural characterization

DOI: 10.5639/gabij.2022.1102.013

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: 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

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

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 list of disturbing world events. This GaBI issue contains manuscripts discussing a variety of topics that are already or promise to be critical to maintaining…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1102.008

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

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 undergo unique patterns of drift and evolution in their manufacturing processes (divergence), ultimately resulting in two products that would be no longer biosimilar. In cases…

Author(s): Pablo Matar, PhD

divergence, drift, evolution, interchangeability, pharmacovigilance, variability

DOI: 10.5639/gabij.2022.1101.006

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