Abstract: Dr Brian Godman reviews Mr Gustaf Befrits’ paper on the case for biosimilars from a payer’s perspective. Biosimilars are increasingly important to payers with growing resource pressures. However, key issues need addressing to fully capture their benefits. Submitted: 17 January 2013; Revised: 4 February 2013; Accepted: 8 February 2013; Published online first: 11 March 2013 Gustaf Befrits has provided us with…

Author(s): Brian Godman, BSc, PhD

biosimilars, economics

DOI: 10.5639/gabij.2013.0201.010

Abstract: Comment on the GaBI Journal article titled The potential for doctors to contribute to biosimilar guidelines [1] and the GaBI Online article titled Dialogue needed to build confidence in biosimilars [2], both by GaBI Journal Editor, Dr Julie Clayton. Submitted: 18 November 2012; Revised: 3 December 2012; Accepted: 4 December 2012; Published online first:…

Author(s): Christoph Baumgärtel, MD, MSc

DOI: 10.5639/gabij.2013.0201.003

Abstract:  Comment on the Letters to the Editor by Dr Carlo Petrini: A bioethicist’s view of the use of biosimilars, published in GaBI Journal, 2012, issue 3-4. Submitted: 9 November 2012; Revised: 12 November 2012; Accepted: 15 November 2012; Published online first: 19 November 2012 In GaBI Journal, 2012, issue 3-4, Dr Carlo Petrini [1] from the Italian National Institute of Health…

Author(s): Christian K Schneider, MD

DOI: 10.5639/gabij.2013.0201.001

Editor's Letter

Published on 19 April 2013

Editor’s introduction to the wide range of topics in the initial issue of the second volume of GaBI Journal

We start off the second year of GaBI Journal with articles covering a wide range of issues. In Letters to the Editor, Dr Christian K Schneider discusses and expands on a previously published article by a bioethicist [1] on the ethics of biosimilars. Dr Schneider applauds the inclusion of ethicists in the debates concerning biosimilars…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0201.015

Many healthcare professionals remain concerned about the safety and efficacy of biosimilars, and are hence reluctant to prescribe them for patients, despite the publication of guidelines for their approval by European regulatory authorities. This level of distrust may reflect a lack of engagement by the regulatory authorities with the medical community during the development of…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0103-4.039

Author byline as per print journal: Sabine Vogler, PhD; Nina Zimmermann, MA Introduction: This Conference Report aims to provide an overview of key results, messages and conclusions of the Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference with regard to generics. Methods: The PPRI Conference, organized by the World Health Organization (WHO) Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies,…

Author(s): Sabine Vogler, PhD, Nina Zimmermann, MA

competition, conference, generics policies, generics uptake, medicine prices, pricing, reimbursement

DOI: 10.5639/gabij.2012.0103-4.030

A recent study by IMS Health Austria (IMS) revealed that in Austria healthcare payers could have saved more than a quarter billion Euros during 2011 if physicians would have prescribed more generics to their patients. The total reimbursed medicines market in Austria totals Euros 1.89 billion. IMS estimates that 89% of the total market by…

Author(s): Christoph Baumgärtel, MD, MSc

DOI: 10.5639/gabij.2012.0103-4.038

Abstract:  The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scientific and technical principles relating to the development and description of the drug substance manufacturing process to be included within the Common Technical Document (CTD) and submitted to…

Author(s): Keith McDonald, MSc, MRPharmS, Kowid Ho, PhD

biotechnological and chemical substances, drug substance quality, ICH Q11

DOI: 10.5639/gabij.2012.0103-4.025

Abstract:  Trade in falsified/counterfeit medical products is a growing global criminal industry, posing a major threat to patients and healthcare systems. Falsified/Counterfeit medical products circulate via unregulated channels, especially the Internet. The Council of Europe’s ‘Convention on counterfeiting of medical products and similar crimes involving threats to public health’ [1] is the first international treaty…

Author(s): Susanne Keitel, MD

Council of Europe, counterfeit medicines, criminalization, falsified medicines, international treaty, MEDICRIME Convention

DOI: 10.5639/gabij.2012.0103-4.029

Abstract:  Communication is a key component in the fight against counterfeit medicines affecting the lives of patients. Two types of risk communication should be distinguished: pro-active and reactive. Reactive communication can be facilitated by appropriate pro-active communication strategies, and healthcare professionals can be powerful allies in communication activities targeting patients. Submitted: 27 July 2012; Revised:…

Author(s): Luc Besançon

counterfeit medicines, healthcare professionals, risk communication

DOI: 10.5639/gabij.2012.0103-4.026

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract:  Biosimilars are firmly established in the EU as copy biologicals with a clear and effective regulatory route for approval. Unfortunately, inconsistency in nomenclature for biosimilars has caused confusion. This problem of terminology has been the subject of a recent publication. The confusion is…

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

comparability, guidelines, non-innovator biologic, quality, safety

DOI: 10.5639/gabij.2012.0103-4.023

Author byline as per print journal: Pieter Dylst, PharmD; Professor Steven Simoens, MSc, PhD; Professor Arnold G Vulto, PharmD, PhD Introduction: A reference pricing system is a system that establishes a common reimbursement level or reference price for a group of interchangeable medicines, i.e. the reference group. This article provides an overview of the different characteristics of the different…

Author(s): Pieter Dylst, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP, Steven Simoens, MSc, PhD

Europe, generic drugs, reference pricing system, reimbursement, review

DOI: 10.5639/gabij.2012.0103-4.028