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

Introduction: The use of biotechnological manufactured drugs, or biologicals, has increased massively over the past few years. Used especially in the treatment of cancer and other severe diseases, biologicals incur high annual therapy costs and represent an additional burden for healthcare systems. Expenditure can be decreased by using cheaper biosimilars, produced following the patent expiration of…

Author(s): Robert Haustein, Christoph de Millas, Ariane Höer, MD, Professor Bertram Häussler, MD

biologicals, biosimilars, cost savings, costs, epo, Europe, G-CSF, MAB

DOI: 10.5639/gabij.2012.0103-4.036

Author byline as per print journal: Thijs J Giezen, PharmD, PhD; Sabine MJM Straus, MD, PhD Abstract:  Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small molecule drugs as well as biologicals, as the full safety profile can only be known after they have been placed on the market. Biologicals have…

Author(s): Sabine MJM Straus, MD, PhD, Thijs J Giezen, PharmD, PhD, MSc

biologicals, biosimilars, immunogenicity, pharmacovigilance, traceability

DOI: 10.5639/gabij.2012.0103-4.033

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:  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:  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