Articles

Pharma News

Published on 06 September 2017

Top developments in biosimilars during 2017

Submitted: 30 January 2018; Revised: 8 February 2018; Accepted: 12 February 2018; Published online first: 26 February 2018 The past year has once again been a busy one for the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.008

11.560 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

15.602 views

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Original Research

Published on 06 September 2017

Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution policies

Introduction/Study objectives: Between March and May 2017, Pfizer conducted an internal global survey of 82 countries examining biosimilar pharmacy-mediated substitution to understand and benchmark the global policy landscape. Methods: Pfizer...

Author(s): Hannah Larkin, Judith Macdonald, Rebecca Lumsden, PhD

biosimilars, global, interchangeability, pharmacy, regulation, substitution

DOI: 10.5639/gabij.2017.0604.034

111.190 views

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Special Report

Published on 28 June 2017

Physician associations comment on FDA’s interchangeability guidance

Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper. Various issues were discussed; this paper highlights...

Author(s): GaBI Journal Editor

biosimilar, extrapolation, interchangeability, labelling, switching, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2017.0603.024

6.584 views

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Published on 21 June 2017

2017/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2017, Issue 2 Editorial Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond Commentary Strategies...

2.479 views

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Editor's Letter

Published on 12 June 2017

What to look forward to in GaBI Journal, 2017, Issue 2

The use both generics and biosimilars offers the potential to increase availability of medicines through decreases in cost that should occur when an expensive product (drug) loses patent protection and...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0602.011

2.817 views

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Meeting Report

Published on 12 June 2017

Value-added medicines: how repurposed medicines bring value to patients and pharmacists

Author byline as per print journal: Christoph Stoller; Professor Stephan Krähenbühl, MD, PhD; Emilia Minodora Voiculescu, PharmD Abstract: The Value Added Medicines Group of Medicines for Europe met at the 2017 European...

Author(s): Christoph Stoller, Emilia Minodora Voiculescu, PharmD, Professor Stephan Krähenbühl, MD, PhD

innovation, pharmacy regulation, value-added medicines

DOI: 10.5639/gabij.2017.0603.027

12.299 views

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Meeting Report

Published on 12 June 2017

Pharmacovigilance, traceability and building trust in biosimilar medicines

Author byline as per print journal: Professor Teun van Gelder, MD, PhD; Benedicte Lunddahl, DVM; Professor Barbara OM Claus, PharmD, PhD Abstract: The Medicines for Europe’s Biosimilar Medicines Group met at the...

Author(s): Barbara OM Claus, PharmD, PhD, Benedicte Lunddahl, DVM, Professor Teun van Gelder, MD, PhD

biological, biosimilar, European Union, pharmacovigilance, regulatory, traceability

DOI: 10.5639/gabij.2017.0603.026

11.781 views

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Review Article

Published on 12 June 2017

Biosimilars in Italy: what do real-world data reveal?

Author byline as per print journal: Assistant Professor Gianluca Trifirò, MD, PhD; Ylenia Ingrasciotta, MSc; Ilaria Marcianò, MSc; Armando A Genazzani, DPhil, MD Abstract: This paper aims to provide an overview...

Author(s): Armando A Genazzani, DPhil, MD, Assistant Professor Gianluca Trifirò, MD, PhD, Ilaria Marcianò, MSc, Ylenia Ingrasciotta, MSc

biosimilars, comparative effectiveness, healthcare administrative databases, real world data, switching

DOI: 10.5639/gabij.2017.0603.023

13.210 views

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Editorial

Published on 12 June 2017

Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond

Abstract: Biosimilars policies are more controversial than those for generics. However, it is only a question of time before progress in biosimilars matches that of generics worldwide. Submitted: 21 April...

Author(s): Alessandro Curto, MSSc

biosimilars, Europe, pricing, reimbursement

DOI: 10.5639/gabij.2017.0602.012

10.503 views

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Special Report

Published on 08 May 2017

Interchangeability of biosimilars in the US and around the world

Abstract: In this paper, differences across the world are highlighted when it comes to the interchangeability of biosimilars. The lack of harmonization makes it difficult for biosimilars makers and could...

Author(s): GaBI Journal Editor

biosimilar, interchangeability

DOI: 10.5639/gabij.2017.0602.017

12.837 views

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