Abstract: An extensive overview of policies related to pharmacy-mediated substitution of biosimilars across the world was carried out by Larkin et al. in 2017. The details of this are discussed in this commentary. Submitted: 17 November 2017; Revised: 28 November 2017; Accepted: 4 December 2017; Published online first: 15 December 2017 Introduction An extensive overview…

Author(s): Thijs J Giezen, PharmD, PhD, MSc

biosimilar, policy, regulation, substitution, switching

DOI: 10.5639/gabij.2017.0604.033

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: 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

Editor's Letter

Published on 15 December 2017

Fourth and final issue of GaBI Journal’s sixth volume

Change is inevitable but often resisted, including or even especially in medicine. Hand washing is still neglected 170 years after Semmelweis’ work, misuse of antibiotics persists 72 years after Fleming warned about it, and use of generics and biosimilars remains suboptimal. This final 2017 issue of the GaBI Journal deals with many of the barriers…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0604.030

Healthcare professionals working with HIV patients in high-income countries are likely to accept the introduction of generic antiretroviral drugs (ARVs), according to a study carried out by researchers in Ireland [1]. Between the end of August and November 2015, 30 healthcare professionals completed an online survey about the introduction of generic ARVs. Descriptive and univariate…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0603.029

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