Rhythm

Published on 15 February 2012

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

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Special Report

Published on 14 February 2012

How matrix models can support generic medicine prescribing

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

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Commentary

Published on 14 February 2012

Innovator companies should focus on innovations

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

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Editorial

Published on 14 February 2012

Generic medicine pricing: on track in Europe?

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

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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

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Perspective

Published on 13 February 2012

Myths, questions, facts about generic drugs in the EU

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

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Perspective

Published on 13 February 2012

Generic and therapeutic orphans

Abstract:  This commentary discusses the need to develop methods to ensure the availability of non-profitable, off-patent medicines to children and other populations. The history and some of the shortcomings of legislative attempts to provide drug therapy to children are briefly reviewed. Some examples of the inability of the current generics and non-generics pharmaceutical industry as…

Author(s): Professor Philip D Walson, MD

off-patent drugs, orphan, paediatric

DOI: 10.5639/gabij.2012.0101.010

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Perspective

Published on 10 February 2012

Generic clopidogrel–the medicines agency’s perspective

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

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