Submitted: 6 December 2018; Revised: 12 December 2018; Accepted: 14 December 2018; Published online first: 19 December 2018 Generic drugs are currently central to disease treatment in the US. However, recent policy concerns have focussed on generics supply inadequacies and the perceived increase in prices of some generic drug products. To further explore the changing…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0704.033

Introduction: Similar Biotherapeutic Products (SBPs or biosimilars) comprise a rapidly expanding area of therapeutics worldwide. However, best practices for their regulation are lacking in many Latin American countries. Methods: The first in a series of educational workshops on SBPs in Latin America was held in Mexico City on 20 January 2015. Didactic presentations covered the…

Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, follow-on drugs, Latin America, Mexico, regulatory practice

DOI: 10.5639/gabij.2015.0403.031

Abstract: This editorial highlights the importance of carrying out comparative studies of patient tolerance to biosimilars and originator products. Minor side effects can affect their acceptability. Submitted: 23 September 2020; Revised: 2 October 2020; Accepted: 6 October 2020; Published online first: 12 October 2020 The previous issue of GaBI Journal published a manuscript entitled ‘Systematic…

Author(s): Professor Alain Astier, PharmD, PhD

DOI: 10.5639/gabij.2020.0904.024

Abstract: Nomenclature for biosimilars is a controversial issue. In this issue of GaBI Journal, a paper by Sarshad et al. considers the US FDA’s published system for this and concludes that it will be a positive solution to a global issue. But this may be a premature judgement. Submitted: 1 January 2019; Revised: 3 January…

Author(s): Robin Thorpe, PhD, FRCPath

biosimilars, INN, nomenclature, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2018.0704.029

Two countries that were affected by the recent economic recession in different ways, and amended their pharmaceutical policies very differently, have provided researchers with an invaluable data set pointing to the strengths and weaknesses of contrasting pharmaceutical sector policies. The use of antipsychotic medicines across Finland and Portugal following the recession has been analysed in…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.049

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 biotherapeutics has significantly evolved in recent years. In particular, monographs on complex biotherapeutics call for greater flexibility as a means of better addressing the structural…

biosimilars, biotherapeutics, monographs, pharmacopoeia, public standards

DOI: 10.5639/gabij.2022.1101.003

Author byline as per print journal: Michael S Reilly, Esq; Jane Barratt, PhD Introduction: The first biosimilar entered the Canadian market in 2009 and the first ophthalmic biosimilar was approved in 2022. In 2022, the Alliance for Safe Biologic Medicines (ASBM) and the International Federation on Ageing (IFA) asked prescribing ophthalmology physicians in Canada for…

biologicals, biosimilars, Canada, ophthalmology

DOI: 10.5639/gabij.2023.1202.008

Submitted: 15 December 2015; Revised: 15 December 2015; Accepted: 15 December 2015; Published online first: 16 December 2015 As a result of recent price increases and shortages, the US generics market has come under increasing scrutiny [1]. In a recent report by Wiske et al., authors from Brown, Duke and Harvard Universities discussed ways to…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.011

Editor's Letter

Published on 14 February 2012

Introduction to the GaBI Journal

I am proud and pleased to be able to write the introduction to this first issue of the Generics and Biosimilars Initiative Journal (GaBI Journal). This journal is designed to complement GaBI Online which has successfully covered generic and biosimilar issues since 2009. The Publisher, the members of our Editorial Boards, and I, that is, ‘we’;…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0101.001

Submitted: 11 February 2015; Revised: 14 February 2015; Accepted: 15 February 2015; Published online first: 20 February 2015 Cancer represents a significant, and growing, burden on healthcare systems around the world. Population growth and ageing will increase the number of new cancer cases in the coming years [1]. Furthermore, cancer is becoming a more widely…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.012

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract: Comment on the Letter to the Editor by Professor Abdol Majid Cheraghali: Access to alternative biopharmaceuticals in low- and middle-income countries, published in GaBI Journal, 2014;4(3):164-5. Submitted: 7 June 2015; Revised: 8 June 2015; Accepted: 8 June 2015; Published online first: 22…

Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2015.0403.024

Author byline as per print journal: Adjunct Professor Valderilio Feijó Azevedo, MD, PhD, MSc; Associate Professor Brian Bressler, MD, MS, FRCPC; Madelaine A Feldman, MD, FACR; Professor Alejandro Mercedes, MD Abstract: As more biological medicines and biosimilars become increasingly available worldwide, clear product identification is critical for accurate pharmacovigilance. Submitted: 25 September 2017; Revised: 25 September…

Author(s): , Alejandro Mercedes, MD, Brian Bressler, MD, Madelaine A Feldman, MD, FACR

Biological Qualifier (BQ), biosimilars, International Nonproprietary Name (INN), naming, pharmacovigilance, World Health Organization (WHO)

DOI: 10.5639/gabij.2017.0604.031