Articles

Review Article

Published on 19 January 2018

The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US

Author byline as per print journal: Hajaj M Alhomaidan; Ali M Alhomaidan, PhD Abstract: This paper describes the differences in human embryonic stem cell regulations in several Christian countries across...

Author(s): Ali M Alhomaidan, PhD, Hajaj M Alhomaidan

regulation, religion, stem cell

DOI: 10.5639/gabij.2018.0701.005

23.279 views

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Review Article

Published on 19 January 2018

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

Author byline as per print journal: Gary L O’Brien1, BPharm, MPharm; Donal Carroll2, BSc (Hon) Pharmacy; Mark Mulcahy3, BComm, MSc, PhD; Valerie Walshe4, BA, MA, PhD; Professor Garry Courtney2, MB, FRCPI;...

Author(s): Professor Garry Courtney, MB, FRCPI, Professor Stephen Byrne, BSc (Hon) Pharmacy, PhD, Gary L O’Brien, BPharm, MPharm, Donal Carroll, BSc (Hon) Pharmacy, Mark Mulcahy, BComm, MSc, PhD, Valerie Walshe, BA, MA, PhD

biologicals, evidence-based, inflammatory bowel disease (IBD), secondary care, switching

DOI: 10.5639/gabij.2018.0701.004

22.078 views

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Original Research

Published on 10 February 2018

Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients

Introduction/Study objectives: A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). API manufacturers generally register API information as a Drug...

Author(s): Maki Matsuhama, MSc, Ryosuke Kuribayashi, PhD

active pharmaceutical ingredients, Drug Master File, generic drugs, globalization, stable supply

DOI: 10.5639/gabij.2018.0701.003

15.425 views

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Commentary

Published on 17 January 2018

EU Member States have tools to reduce costs of bestseller biologicals but can they use them?

Abstract: Major cost savings are achievable in pharmacotherapy in the European Union since biosimilars to most best-selling biological medicinal products have been licensed. Unfortunately, the window of opportunity may be...

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

automatic substitution, biosimilars, cost savings, interchangeability, payers, prescribers

DOI: 10.5639/gabij.2018.0701.002

12.457 views

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Editor's Letter

Published on 10 January 2018

Editor’s introduction to the initial issue of the seventh volume of GaBI Journal

There are many frustrating differences between reality and what is possible in every aspect of life, including politics, economics, science and health. This issue begins with a Commentary by Adjunct...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0701.001

3.014 views

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Abstracted Scientific Content

Published on 17 October 2017

A comparison of European and US generic drug markets

Submitted: 19 June 2017; Revised: 5 September 2017; Accepted: 6 September 2017; Published online first: 19 September 2017 Introduction Comparative research on the European and US generic drug markets based...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.043

32.595 views

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Abstracted Scientific Content

Published on 14 December 2017

Randomized non-inferiority trial fails to find inferiority switching from infliximab originator to CT-P13 biosimilar

Submitted: 17 November 2017; Revised: 20 November 2017; Accepted: 22 November 2017; Published online first: 5 December 2017 The tumour necrosis factor (TNF) inhibitor infliximab is known to significantly improve...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.042

8.817 views

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Research News

Published on 17 October 2017

HIV patients will accept generic treatments

Human immunodeficiency virus (HIV) patients in high-income countries are likely to accept the introduction of generic antiretroviral (ARV) drugs, according to a study carried out by researchers in Ireland [1]....

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.041

3.467 views

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Meeting Report

Published on 13 November 2017

Perspectives on the future of pegfilgrastim biosimilars

Author byline as per print journal: Professor Pere Gascón, MD; Ruediger Jankowsky, PhD; Karsten Roth, PhD Abstract: Cinfa Biotech, the biosimilars specialists of the Cinfa Group, reviewed pegfilgrastim biosimilar approaches to...

Author(s): Karsten Roth, PhD, Professor Pere Gascón, MD, Ruediger Jankowsky, PhD

biosimilars, biotech, G-CSF, neutropenia, pegfilgrastim

DOI: 10.5639/gabij.2017.0604.040

12.808 views

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Special Report

Published on 14 December 2017

USA and Europe differ in interchangeability of biosimilars

Abstract: This paper highlights differences between USA and Europe when it comes to the interchangeability of biosimilars. The lack of harmonization between USA and Europe may introduce confusion for stakeholders...

Author(s): GaBI Journal Editor

biosimilar, EMA, interchangeability

DOI: 10.5639/gabij.2017.0604.039

12.548 views

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Special Report

Published on 13 November 2017

Building stakeholder confidence in biosimilar medicines through evidence-based information sharing

Abstract: The European Commission held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines provided an update of the...

Author(s): Assistant Professor Gianluca Trifirò, MD, PhD

best practice, biosimilar, interchangeability, pharmacovigilance, switching

DOI: 10.5639/gabij.2017.0604.038

5.314 views

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Guidelines

Published on 06 September 2017

Biosimilars in Germany: guidance of the Drug Commission of the German Medical Association

Abstract: Biosimilars have been available in Europe for more than 10 years, but their adoption in Germany has not been very successful. As their pharmaceutical quality, efficacy (particularly in extrapolated...

Author(s): Professor Wolf-Dieter Ludwig, PhD, Stanislava Dicheva, PhD

biologicals, biosimilars, Germany, guidance, switching

DOI: 10.5639/gabij.2017.0604.037

15.542 views

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