Articles

Regulatory

Published on 03 July 2012

Tighter EU rules on pharmacovigilance for biologicals

Received: 27 March 2012; Accepted: 22 May 2012 The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.015

12.151 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

37.443 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

5.571 views

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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...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0101.012

9.119 views

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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...

Author(s): Professor Philip D Walson, MD

off-patent drugs, orphan, paediatric

DOI: 10.5639/gabij.2012.0101.010

11.642 views

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Review Article

Published on 21 February 2012

A review of patient perspectives on generics substitution: what are the challenges for optimal drug use

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...

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

40.241 views

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Review Article

Published on 21 February 2012

European payer initiatives to reduce prescribing costs through use of generics

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,...

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

demand measures, generics, pharmaceuticals, pricing

DOI: 10.5639/gabij.2012.0101.007

57.152 views

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Review Article

Published on 21 February 2012

A patient-centred paradigm for the biosimilars market

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...

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

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

DOI: 10.5639/gabij.2012.0101.006

41.630 views

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Review Article

Published on 21 February 2012

Biologicals and biosimilars: a review of the science and its implications

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...

Author(s): Professor Paul J Declerck, PhD

biological, biopharmaceutical, biosimilar, interchangeability

DOI: 10.5639/gabij.2012.0101.005

76.086 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

233.184 views

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