Articles

Commentary

Published on 02 July 2012

Pharmacovigilance of biosimilars: challenges and possible solutions

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...

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

16.896 views

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Review Article

Published on 02 July 2012

Reference pricing systems in Europe: characteristics and consequences

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...

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

90.071 views

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Original Research

Published on 02 July 2012

Saving money in the European healthcare systems with biosimilars

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...

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

44.481 views

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Editor's Letter

Published on 29 June 2012

What to look forward to in GaBI Journal, 2012, issue 2

It is my pleasure to introduce the second edition of GaBI Journalwhich contains a number of interesting articles. Professors Benjamin and Kearns present a review of advances in paediatric drug...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0102.013

5.565 views

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Perspective

Published on 08 May 2012

Promoting access to biosimilars: a public−private partnership model for biosimilar development in underserved populations

Author byline as per print journal: Timothy Ken Mackey1,2, MAS; Professor Bryan A Liang1,3,4, MD, JD, PhD Abstract:  Biologicals represent the future of pharmaceutical treatments and innovation. Yet, emerging and developing...

Author(s): Professor Bryan A Liang, MD, JD, PhD, Timothy Ken Mackey, MAS

biosimilars, emerging markets, follow-on biologics, global health, immunogenicity, patient safety, public−private partnerships

DOI: 10.5639/gabij.2012.0102.018

23.342 views

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Editorial

Published on 02 May 2012

Equal protection under the law: Children and the Best Pharmaceuticals for Children Act

Abstract:  Four changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act will markedly improve these programmes: expanded attention paid to neonatal studies, support for the...

Author(s): Professor Daniel Kelly Benjamin Jr, MD, MPH, PhD, Professor Gregory L Kearns, PharmD, PhD

Best Pharmaceuticals for Children Act, clinical studies, legislation, neonates, off-patent drugs

DOI: 10.5639/gabij.2012.0102.014

37.417 views

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Special Report

Published on 10 April 2012

The impact of pharmaceutical pricing and reimbursement policies on generics uptake: implementation of policy options on generics in 29 European countries─an overview

Introduction: To describe pharmaceutical pricing and reimbursement systems in 29 European countries with regard to medicines, particularly generics, and their possible impact on generics uptake. Method: Data collection on pharmaceutical pricing and...

Author(s): Sabine Vogler, PhD

generics policies, generics substitution, INN prescribing, pricing, reference pricing system, reimbursement

DOI: 10.5639/gabij.2012.0102.020

57.163 views

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Original Research

Published on 12 March 2012

Ongoing activities to influence the prescribing of proton pump inhibitors within the Scottish National Health Service: their effect and implications

Author byline as per print journal: Professor Brian Godman1,2,3, BSc, PhD; Amanj Kurdi1,4, PhD; Holly McCabe5, MSc; Sean MacBride-Stewart6, MSc; Axel Leporowski5, MD; Simon Hurding7, MD; Professor Marion Bennie1, MSc; Professor...

Author(s): Amanj Kurdi, BSc, PhD, Axel Leporowski, MD, Brian Godman, BSc, PhD, Holly McCabe, MSc, Marion Bennie, MSc, Professor Alec Morton, PhD, Sean MacBride-Stewart, MSc, Simon Hurding, MD

drug utilization, expenditure, generics, PPIs, reforms, Scottish NHS

DOI: 10.5639/gabij.2018.0704.030

12.098 views

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Review Article

Published on 05 March 2012

What lessons can be learned from the launch of generic clopidogrel?

Author byline as per print journal: Christoph Baumgärtel1, MD; Brian Godman2,3,4, BSc, PhD; Rickard E Malmstrom5, MD, PhD; Morten Andersen6, MD, PhD; Mohammed Abuelkhair7, PharmD; Shajahan Abdu7, MD; Marion Bennie8,9, MSc;...

Author(s): Christoph Baumgärtel, MD, MSc, et al.

clopidogrel, demand measures, generics, pricing

DOI: 10.5639/gabij.2012.0102.016

72.210 views

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Guidelines

Published on 05 March 2012

Generics substitution in primary care: summary of the Dutch community pharmacies guidelines

Abstract:  Marketed medicines that have passed bioequivalence testing should in general be substitutable. However, for a variety of reasons, caution may be warranted, particularly with regard to narrow therapeutic index...

Author(s): Leonora Grandia, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP

biologicals, biosimilars, Dutch guidelines, generics substitution, interchangeability, narrow therapeutic index drugs

DOI: 10.5639/gabij.2012.0102.021

18.166 views

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Review Article

Published on 21 February 2012

A review of generic medicine pricing in Europe

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...

Author(s): Steven Simoens, MSc, PhD

Europe, generic medicines, pharmaceutical policy, pricing

DOI: 10.5639/gabij.2012.0101.004

233.051 views

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