Introduction: Switching from originator products to generic equivalents is a key method used by governments to reduce costs and keep their healthcare systems sustainable. The aim of this article is to review generic medicine pricing in Europe by analysing the factors that influence them. Methods: The literature review focused on selected studies that highlighted generic…

Author(s): Steven Simoens, MSc, PhD

Europe, generic medicines, pharmaceutical policy, pricing

DOI: 10.5639/gabij.2012.0101.004

Abstract: Biopharmaceuticals are medicines whose active drug substance is made by living cells. Copies of these drugs, called biosimilars, are not identical to their reference drug and therefore specific regulatory requirements for registration apply. Whereas pharmaceutical quality evaluation requires a full dossier and a detailed comparative analysis to the reference drug, non-clinical and clinical requirements…

Author(s): Professor Paul J Declerck, PhD

biological, biopharmaceutical, biosimilar, interchangeability

DOI: 10.5639/gabij.2012.0101.005

Abstract: The advent of similar biological medicinal products or ‘biosimilars’ in Europe in the 2000s has led to development of a global biosimilars market and regulatory frameworks designed specifically for approval of biosimilars. Like originator biologicals, biosimilars exhibit greater molecular complexity than small-molecule drugs, including generics. Current estimates suggest that biosimilars are more expensive and…

Author(s): James N Class, PhD, Lauren Langis, JD

biosimilars, medical devices, outcomes, patients, prescribers, public policy

DOI: 10.5639/gabij.2012.0101.006

Author byline as per print journal:  Brian Godman1,2,3, BSc, PhD; Bjorn Wettermark1,4, MSc, PhD; Iain Bishop5, BSc; Thomas Burkhardt6, MSc; Jurij Fürst7, PhD; Kristina Garuoliene8, MD; Ott Laius9, MScPharm; Jaana E Martikainen10, Lic Sc(Pharm); Catherine Sermet11, MD; Inês Teixeira12, BA, MSc; Corrine Zara13, PharmD; Lars L Gustafsson1, MD, PhD Introduction: Pharmaceutical expenditure is increasingly scrutinised by payers of health…

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

demand measures, generics, pharmaceuticals, pricing

DOI: 10.5639/gabij.2012.0101.007

Author byline as per print journal: Helle Håkonsen, MScPharm, PhD; Else-Lydia Toverud, MScPharm, PhD Introduction: With a few exceptions, generic drug use has been promoted in western countries by allowing pharmacists to substitute drugs defined as therapeutically equivalent generics. The aim of this literature review is to summarise the research on the patients’ perspectives of generics substitution…

Author(s): Else-Lydia Toverud, MScPharm, PhD, Helle Håkonsen, MScPharm, PhD

cost containment, generic drugs, generics prescribing, generics substitution, patient perspectives

DOI: 10.5639/gabij.2012.0101.008

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

Clinical biosimilar data should be accessible to all Calls are growing for biosimilar manufacturers to publish their data in the public domain, particularly when developing versions of monoclonal antibodies that are associated with potential survival benefits. One of GaBI Online’s readers totally agrees with this message. However, few others wonder why biosimilar producers must handle safety and efficacy data with…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0101.012

Abstract:  This paper describes the design of currently available matrix models and assesses the experience with these models to date. Matrix models provide a valuable tool to facilitate transparent and interactive evidence-based medicine prescribing. In many cases, generically available drugs perform well because of the documented effects on clinically relevant endpoints, good clinical efficacy, extensive…

Author(s): Robert Janknegt, PharmD, PhD

InforMatrix, matrix models, System of Objectified Judgement Analysis (SOJA)

DOI: 10.5639/gabij.2012.0101.011

Abstract: Despite biopharmaceuticals having an enormous potential value for our health, they have also become a serious threat to our healthcare systems. Submitted: 22 June 2011; Revised manuscript received: 6 October 2011; Accepted: 11 October 2011 Recombinant drugs, or biologicals as they are widely termed, are highly complex drug substances that have added tremendous treatment…

Author(s): Professor Theodor Dingermann, PhD

DOI: 10.5639/gabij.2012.0101.003

Abstract: There are many variables responsible for the pricing of generic medicines in Europe. This editorial looks at the many policy initiatives currently being undertaken. Submitted: 3 November 2011; Revised manuscript received: 23 November 2011; Accepted: 14 December 2011 In this first issue of the Generics and Biosimilars Initiative Journal, Professor Steven Simoens describes the…

Author(s): Associate Professor Marc A Koopmanschap, PhD

DOI: 10.5639/gabij.2012.0101.002

Editor's Letter

Published on 14 February 2012

Introduction to the GaBI Journal

I am proud and pleased to be able to write the introduction to this first issue of the Generics and Biosimilars Initiative Journal (GaBI Journal). This journal is designed to complement GaBI Online which has successfully covered generic and biosimilar issues since 2009. The Publisher, the members of our Editorial Boards, and I, that is, ‘we’;…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0101.001

Abstract: Many generic drugs are now being prescribed and the trend is increasing. For example, in Austria, the number of all generics prescriptions has more than doubled from 11% in 2000 to 23% in 2010. However, many myths and questions about generic drugs remain and information may be difficult to come by. It is therefore…

Author(s): Christoph Baumgärtel, MD, MSc

bioequivalence, drug substitution, generics authorisation, legislation, patent, therapeutic equivalency/outcome

DOI: 10.5639/gabij.2012.0101.009