Articles

Editor's Letter

Published on 17 December 2014

Fourth and final issue of GaBI Journal’s third volume

The interest in the development, regulatory approval, use, and post-marketing surveillance of generic and biosimilar pharmaceutical products continues to increase; as illustrated by the tremendous number of views (over 1,028,324...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0304.036

3.808 views

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Original Research

Published on 16 December 2014

What pricing and reimbursement policies to use for off-patent biologicals? – Results from the EBE 2014 biological medicines policy survey

Objective: One of the questions that the advent of biosimilars raises is whether the different nature of biological medicines would also imply the need for a different policy approach by...

Author(s): European Biopharmaceutical Enterprises

biological medicines, biosimilars, off-patent market, pricing and reimbursement policy

DOI: 10.5639/gabij.2015.0401.006

22.341 views

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Original Research

Published on 16 December 2014

Differences in pharmacokinetic behaviour of branded enoxaparin and a US generic version in a non-human primate model

Author byline as per print journal: Professor Walter P Jeske, PhD; Jeanine M Walenga, PhD; Nicolas Simon, MD, PhD; Debra Hoppensteadt, PhD; Josephine Cunanan, MD; Vicki Escalante, BS; Jawed Fareed, PhD;...

Author(s): Debra Hoppensteadt, PhD, Jawed Fareed, PhD, Jeanine M Walenga, PhD, Josephine Cunanan, MD, Mamdouh Bakhos, MD, Nicolas Simon, MD, PhD, Vicki Escalante, BS, Professor Walter P Jeske, PhD

anticoagulation, generics, heparins, pharmacodynamics, pharmacokinetics, population

DOI: 10.5639/gabij.2015.0402.016

32.338 views

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Original Research

Published on 16 December 2014

Payer and physician evidence and discount requirements for biosimilars in three Latin American countries

Study objectives: In Latin America, many governments have attempted to address biosimilar safety and efficacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores...

Author(s): André Vidal Pinheiro, PhD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Daniele Severi Bruni, MPhil, Ronald Halbert, MD, MPH, Erik Sandorff, MA, MBA

biosimilar pharmaceuticals, discounts, drug industry, Latin America, prescribing

DOI: 10.5639/gabij.2015.0401.005

10.256 views

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Commentary

Published on 16 December 2014

The EU regulatory approach to generics and biosimilars is essentially similar

Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach...

Author(s): Barbara J van Zwieten-Boot, Marcel Hoefnagel, Peter MJM Jongen, R Martijn van der Plas

active substance, biosimilar, EMA, Europe, guidelines, regulatory

DOI: 10.5639/gabij.2015.0401.004

11.272 views

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Editorial

Published on 15 December 2014

Availability and procurement of generics in hospitals among medium-sized European countries

Abstract: Dr Brian Godman reviews the paper by Vogler and co-authors on the procurement of generics or originators among European hospitals once multiple sources become available. Submitted: 28 November 2014;...

Author(s): Brian Godman, BSc, PhD

Europe, generics, hospitals, procurement

DOI: 10.5639/gabij.2014.0304.037

9.234 views

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Interview

Published on 12 December 2014

Amgen’s move into the biosimilars market

Abstract: Biotech giant Amgen now has a biosimilars programme that includes nine different molecules. A representative from Amgen has spoken to GaBI about the company’s venture into biosimilars. Topics included...

Author(s): GaBI Journal Editor

biosimilar, naming, uptake

DOI: 10.5639/gabij.2014.0304.048

6.592 views

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Pharma News

Published on 01 December 2014

Reducing the European healthcare budget with generics and biosimilars

The world market for medicinal products is expected to reach US$1 trillion in 2014. Global spending on medicines is expected to grow to nearly US$1.2 trillion by 2017 [1]. As...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.046

7.522 views

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Commentary

Published on 28 November 2014

Biosimilars versus ‘biobetters’—a regulator’s perspective

Abstract: The attractiveness of the biosimilar regulatory pathway is threatened by so-called biobetters. This paper provides definitions and an overview of recent developments. Submitted: 27 October 2014; Revised: 7 November...

Author(s): René Anour, DVM

biobetter, biosimilar, competition, interchangeability, regulatory pathways

DOI: 10.5639/gabij.2014.0304.039

124.222 views

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Published on 04 November 2014

2014/3 GaBI Journal Table of Contents

Contents Editor’s Letter Latest features in GaBI Journal, 2014, Issue 3 Editorial Regional regulatory processes for the approval of biosimilars; differences and similarities Original Research Barriers to market uptake of...

3.345 views

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