Articles

Editor's Letter

Published on 05 December 2013

GaBI Journal publishes four issues in 2013

This issue marks the forth and final issue of the second year’s edition of the GaBI Journal. The journal has grown rapidly through the combined efforts of the publisher and...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0204.042

11.603 views

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Abstracted Scientific Content

Published on 04 December 2013

Biosimilar monoclonal antibodies – time for a regulatory rethink

The approval of biosimilars in the European Union (EU) is governed by the EU biosimilar framework released in 2004. But new arrivals on the biosimilar stage – monoclonal antibodies –...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0203.041

8.932 views

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Editorial

Published on 04 December 2013

Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise?

Abstract: Despite the fact that hepatitis C is a disease of global importance, many countries cannot afford the costly but effective combination treatment of peg-interferon and ribavirin, which was recently...

Author(s): Armando A Genazzani, DPhil, MD, Nicola Magrini, MD

alternative therapeutic products, biosimilar, essential medicines list, peginterferon, regulatory approval pathways, WHO

DOI: 10.5639/gabij.2013.0204.044

20.816 views

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Letters to the Editor

Published on 27 November 2013

Critical immunogenicity differences will be obscured by a common INN for biosimilars

Abstract: Information about variable immunogenicity arising from formulation differences between competing biosimilars is critical for informed judgments by prescribing physicians. Use of a common INN for biosimilars will obfuscate such...

Author(s): Edward T Maggio, PhD

immunogenicity, INN, neoantigen, neutralizing antibodies, oxidative damage, polysorbate, protein aggregation

DOI: 10.5639/gabij.2013.0204.046

6.331 views

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Meeting Report

Published on 18 November 2013

First Asia-Pacific educational workshop on non-biological complex drugs (NBCDs), Kuala Lumpur, Malaysia, 8 October 2013

Author byline as per print journal: Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD, Beat Flühmann, PhD Introduction: In recent years a new category of medicinal products, the non-biological...

Author(s): Beat Flühmann, PhD, Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD

follow-on drugs, nanomedicines, NBCD, non-biologic complex drugs, regulatory practice

DOI: 10.5639/gabij.2014.0301.010

14.161 views

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Special Report

Published on 18 November 2013

Analysis of European policy towards generic medicines

Abstract: In this paper, we provide an overview of a PhD project we undertook on European policy on generic medicines. In the course of our research, we identified various causes...

Author(s): Pieter Dylst, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP, Steven Simoens, MSc, PhD

demand-side policies, Europe, European policy, generic medicines, supply-side policies

DOI: 10.5639/gabij.2014.0301.011

16.426 views

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Perspective

Published on 18 November 2013

Role of hospital clinical pharmacist in transplantation, and generic immunosuppressive therapies

Abstract: The pharmacist is an important patient advocate in the transplant multidisciplinary team and can support patients in their medication taking to improve medication adherence. Medicine optimization and patient information...

Author(s): Andrea Devaney

generics substitution, immunosuppressant, self-medication, tacrolimus, transplantation

DOI: 10.5639/gabij.2014.0302.023

26.091 views

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Letters to the Editor

Published on 12 November 2013

Biosimilars naming and prescribing policy in Australia

Submitted: 31 October 2013; Revised: 6 November 2013; Accepted: 11 November 2013; Published online first: 25 November 2013 To the Editor: I wanted to bring to your attention the following...

Author(s): Brendan Shaw, PhD

DOI: 10.5639/gabij.2013.0204.048

8.939 views

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Letters to the Editor

Published on 29 October 2013

Legislative efforts to limit prescription information sharing between patients and healthcare providers represent a serious threat to the health and safety of the American nation

Abstract: Legislation in support of pharmacist notification to patients and providers of substitution of an interchangeable biologic for the originator biologic was recently vetoed in California. Automatic substitution of approved...

Author(s): Janet S Wyatt, RN, PhD, FAANP

biologicals, patients, REMS

DOI: 10.5639/gabij.2013.0204.045

6.560 views

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Editorial

Published on 29 October 2013

Suggested evaluation of biological drugs role for WHO – Editor’s response

Abstract: The Editor-in-Chief expresses his concerns about the proposal of a WHO run system to approve copy biologicals in the Milani and Gaspani paper [1]. The paper by Milani and...

Author(s): Professor Philip D Walson, MD

biological products, pegylated interferons, WHO

DOI: 10.5639/gabij.2013.0204.043

13.306 views

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Meeting Report

Published on 30 September 2013

The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead?

Author byline as per print journal: Professor Stefan Mühlebach, PhD, Professor Arnold Vulto, PharmD, PhD, Jon SB de Vlieger, PhD, Vera Weinstein, PhD, Beat Flühmann, PhD, Vinod P Shah, PhD...

Author(s): Beat Flühmann, PhD, Jon SB de Vlieger, PhD, Professor Arnold G Vulto, PharmD, PhD, FCP, Professor Stefan Mühlebach, PhD, Vera Weinstein, PhD, Vinod P Shah, PhD

glatiramoids, iron sucrose, liposomes, nanomedicines, NBCD, similars

DOI: 10.5639/gabij.2013.0204.054

55.397 views

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