Articles

Original Research

Published on 14 December 2016

Naming and labelling of biologicals – a survey of US physicians’ perspectives

Introduction: The US Food and Drug Association (FDA) released its requirements for the non-proprietary naming of biological products in January 2017. Before the FDA’s release, the Alliance for Safe Biologic...

Author(s): Harry L Gewanter, MD, FAAP, FACR, Michael S Reilly, Esq

ASBM, biosimilar, interchangeability, labelling, legislation, naming

DOI: 10.5639/gabij.2017.0601.003

10.426 views

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Abstracted Scientific Content

Published on 14 December 2016

An empirical study of market-based purchasing policies for generic pharmaceuticals in Sweden

Submitted: 1 December 2016; Revised: 6 December 2016; Accepted: 7 December 2016; Published online first: 12 December 2016 In Sweden, the government funds an insurance programme covering 75–80% of the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.050

4.102 views

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Special Report

Published on 12 December 2016

The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products

Abstract: European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic products have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such...

Author(s): Emmanuelle Charton, PhD

biotherapeutic products, complexity of biologicals, monographs, pharmacopoeia, public standards

DOI: 10.5639/gabij.2016.0504.045

20.470 views

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Abstracted Scientific Content

Published on 12 December 2016

Strategies used to delay or prevent access to affordable generic drugs in the US

Submitted: 28 November 2016; Revised: 29 November 2016; Accepted: 30 November 2016; Published online first: 5 December 2016 In the journal Blood, Jones et al. [1] discuss strategies used by...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.051

5.017 views

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Abstracted Scientific Content

Published on 31 October 2016

Essential information for internists on biologicals and biosimilars

Submitted: 21 November 2016; Revised: 22 November 2016; Accepted: 24 November 2016; Published online first: 30 November 2016 Authors from the IRCCS – Istituto di Ricerche Farmacologiche ‘Mario Negri’, Milan,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.049

4.121 views

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Abstracted Scientific Content

Published on 31 October 2016

Effect of naming on pharmacists’ perceptions and dispensing of biosimilars

Submitted: 21 November 2016; Revised: 22 November 2016; Accepted: 24 November 2016; Published online first: 30 November 2016 A study of pharmacists investigated their perceptions of biosimilar naming conventions and...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.048

6.963 views

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Published on 31 October 2016

2016/3 GaBI Journal Table of Contents

Contents Editor’s Letter Latest features in GaBI Journal, 2016, Issue 3 Letters to the Editor Is the EU ready for non-biological complex drug products? Commentary Biosimilars: achieving long-term savings and...

2.532 views

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Letters to the Editor

Published on 26 October 2016

Is the EU ready for non-biological complex drug products?

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Gerrit Borchard, PharmD, PhD; Vinod P Shah, PhD; Beat Flühmann, PhD; Sesha Neervannan, PhD; Professor Stefan Mühlebach, PhD...

Author(s): Beat Flühmann, PhD, Jon SB de Vlieger, PhD, Professor Gerrit Borchard, PharmD, PhD, Professor Stefan Mühlebach, PhD, Sesha Neervannan, PhD, Vinod P Shah, PhD

complex drug products, EMA, generics, harmonization, non-biological complex drug (NBCD), therapeutic equivalence, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2016.0503.026

7.154 views

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Editor's Letter

Published on 26 October 2016

Latest features in GaBI Journal, 2016, Issue 3

The informed, appropriate use of follow-on pharmacological agents can provide significant cost savings for patients and payers. These savings can then be used by governments and patients to increase access...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0503.025

3.157 views

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Regulatory

Published on 26 October 2016

Regulatory Science Ireland: bridging the information gap on biosimilar medicines

Author byline as per print journal: Joan O’Callaghan, BSc Pharm; Sean Barry, PhD; Una Moore, PhD; Margaret Bermingham, PhD; J Michael Morris, PhD; Frank Hallinan, PhD; Brendan T Griffin, PhD Abstract: Regulatory...

Author(s): Brendan T Griffin, PhD, Frank Hallinan, PhD, J Michael Morris, PhD, Joan O’Callaghan, BSc Pharm, Margaret Bermingham, PhD, Sean Barry, PhD, Una Moore, PhD

biological medicines, biosimilar, Health Products Regulatory Authority, regulatory science, Regulatory Science Ireland

DOI: 10.5639/gabij.2016.0504.043

9.410 views

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Commentary

Published on 26 October 2016

Potential changes to the FDA approach to biosimilars have a global impact

Abstract: The Opinion article of Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its guidance on biosimilar development. This article comments on some of the...

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

automatic substitution, FDA guidelines, global reference product, information, interchangeability, regulatory harmonization

DOI: 10.5639/gabij.2018.0702.011

7.864 views

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Review Article

Published on 26 October 2016

Cost-minimization analysis of generic equivalents (bortezomib, decitabine and capecitabine) in comparison to the originator brand medicines in Colombia

Author byline as per print journal: Shyam Akku, MD; Amit Garg, MD; Suhas Khandarkar, MPharm Introduction: Majority of the Colombian population has become health insured leading to improved healthcare access in...

Author(s): Amit Garg, MD, Shyam Akku, MD, Suhas Khandarkar, MPharm

anticancer drugs, cost-minimization, generics, pharmacoeconomics

DOI: 10.5639/gabij.2016.0504.042

15.908 views

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