Submitted: 19 June 2017; Revised: 5 September 2017; Accepted: 6 September 2017; Published online first: 19 September 2017 Introduction Comparative research on the European and US generic drug markets based on 2013 IMS data across 13 European countries with different generic drug policies has recently been accepted for publication in the Milbank Quarterly [1], and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.043

Author byline as per print journal: Mohammad Bashaar, PhD; Professor Mohamed Azmi Hassali, PhD; Fahad Saleem, PhD Abstract: The soaring costs of medicine are a global dilemma. It was hoped that the concept of essential medicines would help countries and policymakers contain the climbing costs of medicine over the last 40 years. This concept was conceived to…

Author(s): Fahad Saleem, Mohammad Bashaar, Professor Mohamed Azmi Hassali, PhD

access barriers, affordability, essential medicines, medicine prices

DOI: 10.5639/gabij.2017.0604.036

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, 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

Contents Editor’s Letter Latest features in GaBI Journal, 2017, Issue 3 Commentary Patent expiry and costs for anti­cancer medicines for clinical use Original Research A survey of Australian prescribers’ views on the naming and substitution of biologicals Review Article Biosimilars in Italy: what do real-world data reveal? Special Report Physician associations comment on FDA’s interchangeability…

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

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

Submitted: 30 January 2018; Revised: 8 February 2018; Accepted: 12 February 2018; Published online first: 26 February 2018 The past year has once again been a busy one for the biosimilars industry. Important milestones achieved during 2017 were the biosimilar approvals of Renflexis (infliximab-abda), Cyltezo (adalimumab-adbm), Mvasi (bevacizumab-awwb), Ixifi (infliximab-qbtx) and Ogivri (trastuzumab-dkst), along with…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.008

Abstract: Biosimilars have been available in Europe for more than 10 years, but their adoption in Germany has not been very successful. As their pharmaceutical quality, efficacy (particularly in extrapolated indications), safety (especially immunogenicity) and interchangeability with reference products have been controversially discussed by healthcare professionals, the Drug Commission of the German Medical Association developed…

Author(s): Professor Wolf-Dieter Ludwig, PhD, Stanislava Dicheva, PhD

biologicals, biosimilars, Germany, guidance, switching

DOI: 10.5639/gabij.2017.0604.037

Introduction/Study objectives: Between March and May 2017, Pfizer conducted an internal global survey of 82 countries examining biosimilar pharmacy-mediated substitution to understand and benchmark the global policy landscape. Methods: Pfizer regulatory and corporate affairs colleagues completed a survey: Are pharmacists in your country able to substitute a biological with a biosimilar without the physician being…

Author(s): Hannah Larkin, Judith Macdonald, Rebecca Lumsden, PhD

biosimilars, global, interchangeability, pharmacy, regulation, substitution

DOI: 10.5639/gabij.2017.0604.034

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

Contents Editor’s Letter What to look forward to in GaBI Journal, 2017, Issue 2 Editorial Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond Commentary Strategies for pricing of pharmaceuticals and generics in developing countries Original Research What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results…