Author byline as per print journal: Adjunct Professor Valderilio Feijó Azevedo, MD, PhD, MBA; 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, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, 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

Abstract: Comment on the Special Report by Professor Gerrit Borchard: Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias, published in GaBI Journal, 2016;5(1):36-41. Submitted: 3 November 2017; Revised: 13 November 2017; Accepted: 15 November 2017; Published online first: 28 November 2017 We thank you for publishing the manuscript entitled ‘Complexity in the making: non-biological…

Author(s): Karthik Bodhinathan, PhD, MSM

Glatiramer acetate, multiple sclerosis, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2017.0604.032

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

Abstract: The European Commission held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines provided an update of the latest available clinical experiences with biosimilar medicines, focusing on switching between biological medicines and interchangeability. Assistant Professor Gianluca Trifirò from the University of Messina, Italy,…

Author(s): Assistant Professor Gianluca Trifirò, MD, PhD

best practice, biosimilar, interchangeability, pharmacovigilance, switching

DOI: 10.5639/gabij.2017.0604.038

A patient-centred paradigm for the biosimilars market This article provides important insights into the use and application of complex biologicals, particularly biosimilars, in health delivery systems. One aspect of care that has been traditionally ignored by providers as well as the private sector is the patient experience. Although much has been said about ‘patient-centeredness’, what this means generally is lip…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.024

Submitted: 6 March 2015; Revised: 9 March 2015; Accepted: 10 March 2015; Published online first: 23 March 2015 A new online resource on biological and biosimilar medicines in Latin America – created for patients, the organizations who represent them and those who want to understand more about how these issues affect patients in the region…

Author(s): Ian Ford

DOI: 10.5639/gabij.2015.0402.021

Submitted: 21 November 2018; Revised: 22 November 2018; Accepted: 28 November 2018; Published online first: 4 December 2018 A study published by the World Health Organization (WHO) compares the effect of different pricing policies for generic medicines in four countries [1]. Using atorvastatin as a case study, their results show that price cuts combined with…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0703.027

Abstract: Clinical trials must demonstrate biosimilarity for regulatory marketing approval to be granted. The GaBI Journal has conducted a search for clinical trials that have been, or are being, carried out for trastuzumab biosimilars. Submitted: 26 March 2020; Revised: 2 April 2020; Accepted: 2 April 2020; Published online first: 15 April 2020 Roche’s originator trastuzumab…

Author(s): GaBI Journal Editor

biosimilar, clinical trials, trastuzumab

DOI: 10.5639/gabij.2020.0902.014

Abstract: Around the world, especially in low- and middle-income countries, national regulatory authorities are struggling with registration backlogs and the affordability of medicines. This paper draws on the example of cancer biosimilars in South Africa to illustrate how non-governmental organizations can help regulatory authorities decide which registration applications to prioritize by providing information on clinical…

Author(s): Paul Malherbe, PhD

biosimilars, non-governmental organizations, registration backlog, regulation

DOI: 10.5639/gabij.2020.0901.004

Submitted: 19 January 2017; Revised: 20 January 2017; Accepted: 23 January 2017; Published online first: 6 February 2017 In an article published in US Pharmacist [1] Manigault et al. emphasize a number of barriers that still exist to effective generics substitution in the US, and show how pharmacists, with some knowledge and insight, can help…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0602.019

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

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