Abstract:  In recognition of the many ethically sensitive issues raised by the production and use of biosimilar medicinal products, the author imagines having to answer the non-multiple choice question ‘From the ethical point of view, what is the most important issue raised by biosimilars?’, and endeavours to explain why the proposed answer is ‘safety’. Submitted:…

Author(s): Carlo Petrini, PhD

bioethics, drugs, ethics committees, legislation, risk, safety

DOI: 10.5639/gabij.2012.0103-4.034

Abstract:  Dylst et al. provide a detailed overview about the characteristics of reference price systems in Europe and discuss their possible impact. The role of stakeholders in the implementation of this policy measure requires further attention. Submitted: 16 September 2012; Revised: 17 September 2012; Accepted: 19 September 2012; Published online first: 21 September 2012 Dylst…

Author(s): Sabine Vogler, PhD

generics policies, health professionals, patients, reference price system, reimbursement

DOI: 10.5639/gabij.2012.0103-4.031

Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese drug regulatory agency, sharing responsibilities with the Ministry of Health, Labour and Welfare. Its mission is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. This paper introduces PMDA’s current situation (until spring 2012) including its organisational…

Author(s): Yuki Ando, BA, Toshiyoshi Tominaga, PhD, Tatsuya Kondo, MD, PhD

approval review, international strategy, Japanese regulatory authority, PMDA, regulatory science, safety measure

DOI: 10.5639/gabij.2013.0201.013

Abstract:  A study presented at the 2010 Congress of the European Society of Cardiology, had created a considerable stir. Its abstract allegedly showed that the originator drug Lipitor was more beneficial than any of its generic statin equivalents. But, in fact the study merely showed that the different potencies of statins were not taken adequately…

Author(s): Christoph Baumgärtel, MD, MSc

cardiovascular risk, generics, inferiority, potency, statins

DOI: 10.5639/gabij.2012.0103-4.032

Abstract:  Vogler and Zimmerman, reporting on the 2011 Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference, have noted the incomplete application of generics policies in many settings, and have called for more consistent policies. While many of the basic building blocks of such policies are well described, some elements required renewed attention. Submitted: 23 July 2012;…

Author(s): Andy Gray, MScPharm, FPS, FFIP

generics policies, transparency, WHO policy

DOI: 10.5639/gabij.2012.0103-4.027

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

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

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

Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care Oncologists have been urged to embrace biosimilar drug substitution to help control the spiralling costs of cancer care. However, they have been warned that the optimal realisation of such a programme requires successful educational initiatives and the development of effective working partnerships with pharmacists and patients [1].…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.022

Received: 27 March 2012; Accepted: 22 May 2012 The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as well as the regulations surrounding biosimilars and automatic substitution by pharmacists. The new regulations will provide a legal framework for patients to report adverse events…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.015

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: 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