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, BSc; Rajavikraman Boopathy1, DipSc; Shahnun Ahmad1, MBBS; Atiqah Amran1, BSc; Raman Batheja2, PhD; Rajan Sharma2>, MBBS; Kiran Kumar Vuppalavanchu2, MPharm Introduction/Study Objectives: The aim of…

bioequivalence, new branded generics, pharmacokinetics, sitagliptin

DOI: 10.5639/gabij.2023.1201.003

Abstract: The Opinion published in this issue of GaBI Journal titled ‘Biosimilars drug development: time for a paradigm shift?’ by Sandeep N Athalye, Shivani Mittra and Ankitkumar M Ranpur proposes a number of changes to the regulatory processes currently in place for biosimilars. This response letter considers the implications and consequences of these. Submitted: 8 December…

Author(s): Robin Thorpe, PhD, FRCPath

biosimilars, clinical trials, guidance, immunogenicity, regulatory

DOI: 10.5639/gabij.2023.1201.002

Editor's Letter

Published on 03 May 2023

Lagging acceptance of generic and biosimilar drug products; the rest of the story

The article in this issue of the GaBI Journal reminded me of The Rest of the Story radio programme originally hosted by Mr Paul Harvey that started each episode with, ‘And now for the rest of the story’. This is because these articles illustrate that sometimes what is not discussed in an article can be…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2023.1201.001

Introduction: Biosimilars were first introduced in Europe in 2006 and then in the US in 2015. An online webinar on the successful uptake in Europe and the US was held to discuss measures taken for improving biosimilar uptake, and trends in uptake. Methods: The webinar was held by the Alliance for Safe Biologic Medicines (ASBM)…

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP

biosimilars, health policies, physicians, prescribing, uptake

DOI: 10.5639/gabij.2022.1103.018

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 feasibility study, importance of interaction with stakeholders and the challenges and lessons learned are discussed. Emphasis is put on the approach used to set the…

Author(s): Mihaela Buda, PhD

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

DOI: 10.5639/gabij.2022.1103.017

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