Abstract:  Comment on the Letters to the Editor by Dr Carlo Petrini: A bioethicist’s view of the use of biosimilars Submitted: 8 October 2012; Revised: 9 October 2012; Accepted: 9 October 2012; Published online first: 11 October 2012 In the European Union the word ‘biosimilar’ denotes a copy version of an already authorized biological medicinal product with…

Author(s): Dr Kalle Hoppu

DOI: 10.5639/gabij.2012.0103-4.035

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

Editor's Letter

Published on 14 November 2012

Latest features in GaBI Journal, 2012, issue 3-4

This issue of the GaBI Journal uses a number of article formats to cover a range of issues related to generics and biosimilars. In Letters to the Editor, Dr Carlo Petrini presents and defends the suggestion that the clinical use of biosimilars poses ethical concerns that differ from those of other pharmaceutical products. He even…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0103-4.037

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

Abstract:  Marketed medicines that have passed bioequivalence testing should in general be substitutable. However, for a variety of reasons, caution may be warranted, particularly with regard to narrow therapeutic index drugs and the indiscriminate use of biosimilars. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharmacies concerning generic substitution. The guidelines…

Author(s): Leonora Grandia, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP

biologicals, biosimilars, Dutch guidelines, generics substitution, interchangeability, narrow therapeutic index drugs

DOI: 10.5639/gabij.2012.0102.021

Introduction: To describe pharmaceutical pricing and reimbursement systems in 29 European countries with regard to medicines, particularly generics, and their possible impact on generics uptake. Method: Data collection on pharmaceutical pricing and reimbursement policies with the staff of competent authorities. Results: In most European countries the prices of medicines are controlled at the stage of manufacture (ex-factory price)…

Author(s): Sabine Vogler, PhD

generics policies, generics substitution, INN prescribing, pricing, reference pricing system, reimbursement

DOI: 10.5639/gabij.2012.0102.020

Abstract:  A number of generic products containing clopidogrel as the active substance have been marketed in Austria and the EU for some time. Due to different clopidogrel salt preparations and different indications, doubts arose as to whether the products could be considered as equivalent. The Austrian Federal Office for Safety in Health Care (BASG)/The Austrian Agency for Health and Food Safety…

Author(s): Christoph Baumgärtel, MD, MSc

bioequivalence, clopidogrel, drug substitution, drugs, generics, therapeutic equivalence

DOI: 10.5639/gabij.2012.0102.019

Author byline as per print journal: Timothy Ken Mackey1,2, MAS; Professor Bryan A Liang1,3,4, MD, JD, PhD Abstract:  Biologicals represent the future of pharmaceutical treatments and innovation. Yet, emerging and developing markets lack access to these often essential medicines. Biosimilar development represents a potential solution to this problem, by offering lower cost and improved access, but…

Author(s): Professor Bryan A Liang, MD, JD, PhD, Timothy Ken Mackey, MAS

biosimilars, emerging markets, follow-on biologics, global health, immunogenicity, patient safety, public−private partnerships

DOI: 10.5639/gabij.2012.0102.018

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Mohammed Abuelkhair4, PharmD; Agnes Vitry5, PharmD, PhD; Shajahan Abdu4, MD; Marion Bennie6,7, MSc; Iain Bishop7, BSc; Sahar Fahmy4, PhD; Kristina Garuoliene8, MD, PhD; Harald Herholz9, MPH; Andrew Martin10, BSc, MPharmS; Rickard E Malmstrom11, MD, PhD; Professor Saira Jan12,13, PharmD, PhD; Ulrich Schwabe14, MD, PhD; Catherine Sermet15,…

Author(s): Brian Godman, BSc, PhD, et al.

demand-side measures, generics, pharmaceuticals, pricing

DOI: 10.5639/gabij.2012.0102.017

Author byline as per print journal: Christoph Baumgärtel1, MD; Brian Godman2,3,4, BSc, PhD; Rickard E Malmstrom5, MD, PhD; Morten Andersen6, MD, PhD; Mohammed Abuelkhair7, PharmD; Shajahan Abdu7, MD; Marion Bennie8,9, MSc; Iain Bishop9, BSc; Thomas Burkhardt10, MSc; Sahar Fahmy7, PhD; Jurij Furst11; Kristina Garuoliene12, MD, PhD; Harald Herholz13, MPH; Marija Kalaba14, MD, MHM; Hanna Koskinen15, PhD;…

Author(s): Christoph Baumgärtel, MD, MSc, et al.

clopidogrel, demand measures, generics, pricing

DOI: 10.5639/gabij.2012.0102.016

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

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