Submitted: 13 September 2017; Revised: 17 September 2017; Accepted: 18 September 2017; Published online first: 25 September 2017 Both pharmacists and doctors in Guatemala lack trust in generic medicines, according to a study carried out by a local non-governmental organization (NGO) [1]. The authors make recommendations for increasing generics uptake, including changing dispensing practices and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0603.028

Author byline as per print journal: Christoph Stoller; Professor Stephan Krähenbühl, MD, PhD; Emilia Minodora Voiculescu, PharmD Abstract: The Value Added Medicines Group of Medicines for Europe met at the 2017 European Association of Hospital Pharmacists conference in France to discuss the merits and future of these medicines. Submitted: 13 June 2017; Revised: 23 August 2017; Accepted:…

Author(s): Christoph Stoller, Emilia Minodora Voiculescu, PharmD, Professor Stephan Krähenbühl, MD, PhD

innovation, pharmacy regulation, value-added medicines

DOI: 10.5639/gabij.2017.0603.027

Author byline as per print journal: Professor Teun van Gelder, MD, PhD; Benedicte Lunddahl, DVM; Professor Barbara OM Claus, PharmD, PhD Abstract: The Medicines for Europe’s Biosimilar Medicines Group met at the 2017 European Association of Hospital Pharmacists conference in France to discuss pharmacovigilance, traceability and building trust in biosimilar medicines. Submitted: 22 May 2017; Revised: 21…

Author(s): Barbara OM Claus, PharmD, PhD, Benedicte Lunddahl, DVM, Professor Teun van Gelder, MD, PhD

biological, biosimilar, European Union, pharmacovigilance, regulatory, traceability

DOI: 10.5639/gabij.2017.0603.026

Author byline as per print journal: Stuart Bloom, DM, FRCP; Keith Bodger, MBChB(Honours), MD, FRCP; Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP; Professor Sarah Garner, BPharm, PhD; Professor Kimme Hyrich, MD, PhD, FRCPC; Clare Jacklin; Professor John G Williams, CBE, FRCP Introduction: Registries collect clinical data to evaluate specified outcomes for a population defined by a particular disease, condition…

Author(s): Clare Jacklin, Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP, Keith Bodger, MBChB(Honours), MD, FRCP, Professor John G Williams, CBE, FRCP, Professor Kimme Hyrich, MD, PhD, FRCPC, Professor Sarah Garner, BPharm, PhD, Stuart Bloom, DM, FRCP

biologicals, biosimilars, monoclonal antibodies, pharmacovigilance, registries, regulation

DOI: 10.5639/gabij.2017.0603.025

Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper. Various issues were discussed; this paper highlights the comments on extrapolation, interchangeability, switching, labelling and naming, post-marketing and disease experts. Submitted: 2 June 2017; Revised: 13 June 2017; Accepted: 13 June 2017;…

Author(s): GaBI Journal Editor

biosimilar, extrapolation, interchangeability, labelling, switching, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2017.0603.024

Author byline as per print journal: Assistant Professor Gianluca Trifirò, MD, PhD; Ylenia Ingrasciotta, MSc; Ilaria Marcianò, MSc; Armando A Genazzani, DPhil, MD Abstract: This paper aims to provide an overview of the available real-world data about the pattern of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy. Different observational studies…

Author(s): Armando A Genazzani, DPhil, MD, Assistant Professor Gianluca Trifirò, MD, PhD, Ilaria Marcianò, MSc, Ylenia Ingrasciotta, MSc

biosimilars, comparative effectiveness, healthcare administrative databases, real world data, switching

DOI: 10.5639/gabij.2017.0603.023

Author byline as per print journal: Stephen P Murby, FRSA; Michael S Reilly, Esq Introduction: As the number of biosimilar approvals in Australia increases, it is important to build on the existing regulatory framework to continue to bring high quality, safe and efficacious biosimilars to the widest number of patients most cost-effectively. As new policies regarding…

Author(s): Michael S Reilly, Esq, Stephen P Murby, FRSA

Australia, biologicals, labelling, naming, prescribers

DOI: 10.5639/gabij.2017.0603.022

Author byline as per print journal: Brian Godman, BSc, PhD; Claudia Wild, PhD; Alan Haycox, PhD Abstract: Venkatesan S et al. have researched patent rights and pricing for (non-)tyrosine kinase inhibitors. It is not clear why the patent rights are so long and why prices of (non-)tyrosine kinase inhibitors can be high. These issues are discussed.…

Author(s): Alan Haycox, PhD, Brian Godman, BSc, PhD, Claudia Wild, PhD

cancer medicines, generics, health gain, prices, tyrosine kinase inhibitors (TKI)

DOI: 10.5639/gabij.2017.0603.021

Editor's Letter

Published on 27 September 2017

Latest features in GaBI Journal, 2017, Issue 3

It is clear that greater use of generics and biosimilars could greatly decrease healthcare costs and thereby increase availability of important medicines. It is equally clear that these potential savings are seldom achieved. The disconnect between what is possible and what is being achieved is related to a lack of trust on behalf of patients,…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0603.020

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

Submitted: 13 March 2017; Revised: 15 March 2017; Accepted: 16 March 2017; Published online first: 29 March 2017 Generic drug manufacturing of four major cancer drugs could massively reduce their costs to the National Health Service in the UK, according to a study published in the British Medical Journal [1]. The study shows that generics…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0602.018

Abstract: In this paper, differences across the world are highlighted when it comes to the interchangeability of biosimilars. The lack of harmonization makes it difficult for biosimilars makers and could possibly delay access to life-saving treatments. Submitted: 6 April 2017; Revised: 14 April 2017; Accepted: 14 April 2017; Published online first: 28 April 2017 There…

Author(s): GaBI Journal Editor

biosimilar, interchangeability

DOI: 10.5639/gabij.2017.0602.017