Articles

Published on 22 October 2014

2013/1 GaBI Journal Table of Contents

Contents Editor's Letter Editor’s introduction to the wide range of topics in the initial issue of the second volume of GaBI Journal Letters to the Editor The ethics of biosimilars...

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Published on 22 October 2014

2012/3-4 GaBI Journal Table of Contents

Contents Editor's Letter Latest features in GaBI Journal, 2012, issue 3-4 Letters to the Editor A bioethicist’s view of the use of biosimilars A clinician’s view of the ethics of...

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Published on 22 October 2014

2012/2 GaBI Journal Table of Contents

Contents Editor's Letter What to look forward to in GaBI Journal, 2012, issue 2 Editorial Equal protection under the law: Children and the Best Pharmaceuticals for Children Act Regulatory Tighter...

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Published on 16 October 2014

2012/1 GaBI Journal Table of Contents

Contents Editor's Letter Introduction to the GaBI Journal Editorial Generic medicine pricing: on track in Europe? Commentary Innovator companies should focus on innovations Review Article A review of generic medicine...

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Regulatory

Published on 23 September 2014

Regulation of biologicals in Malaysia

Abstract: The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises...

Author(s): Arpah Abas, BPharm, Yvonne Siew Khoon Khoo, BPharm (Hons) MMedSc, PhD (Pharmacology)

biologicals, evaluation, Malaysia, National Pharmaceutical Control Bureau (NPCB), regulation

DOI: 10.5639/gabij.2014.0304.044

17.777 views

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Abstracted Scientific Content

Published on 23 September 2014

Pharmaceutical policy interventions in times of economic recession

Two countries that were affected by the recent economic recession in different ways, and amended their pharmaceutical policies very differently, have provided researchers with an invaluable data set pointing to...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.049

5.979 views

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Review Article

Published on 05 September 2014

Safety assessment of biosimilars in Europe: a regulatory perspective

Abstract: Clinical safety is important during the development of a biosimilar. This paper provides an overview of the main aspects related to the safety assessment of biosimilars. The European Medicines...

Author(s): Christian K Schneider, MD, Thijs J Giezen, PharmD, PhD, MSc

biosimilar, clinical safety, immunogenicity, pharmacovigilance

DOI: 10.5639/gabij.2014.0304.041

13.885 views

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Editor's Letter

Published on 05 September 2014

Latest features in GaBI Journal, 2014, Issue 3

This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0303.026

4.721 views

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Opinion

Published on 02 September 2014

Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe

Abstract: The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar development. However,...

Author(s): European Biopharmaceutical Enterprises

biosimilars, EMA (European Medicines Agency), labels, PIL (product information leaflet), Summary of Product Characteristics (SmPC)

DOI: 10.5639/gabij.2014.0304.043

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Letters to the Editor

Published on 02 September 2014

Access to alternative biopharmaceuticals in low- and middle-income countries

Abstract: Alternative biopharmaceuticals could substantially improve affordability of biotherapeutics in developing countries. However, it seems that these countries need a modified regulatory pathway to guarantee timely access to these medicines....

Author(s): Professor Abdol Majid Cheraghali, PharmaD, PhD

affordability, alternative biopharmaceuticals, regulation

DOI: 10.5639/gabij.2014.0304.038

6.368 views

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Original Research

Published on 02 September 2014

Availability and procurement conditions of originator and generic medicines in hospitals – an exploratory study in five medium-sized European countries

Aim: To explore whether medicines used in hospitals in European countries are supplied as originators or generic medicines, and to investigate the procurement conditions, including the extent of discounts at...

Author(s): Sabine Vogler, PhD, Nina Zimmermann, MA, Jan Mazag, PharmaDr

cardiovascular medicines, discounts, generics, procurement, rebates, tender

DOI: 10.5639/gabij.2014.0304.040

11.028 views

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