Articles

Meeting Report

Published on 12 March 2015

2014 World Transplant Congress, San Francisco, California, USA, 26–31 July 2014

This was a joint meeting of the American Society of Transplant Surgeons (ASTS), The Transplant Society (TTS) and the American Society of Transplantation (ATS). The Congress was packed with an...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0304.047

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Pharma News

Published on 06 March 2015

Top developments in biosimilars during 2014

Submitted: 10 February 2015; Revised: 24 February 2015; Accepted: 25 February 2015; Published online first: 6 March 2015 The past year has once again been a busy one for the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.010

11.729 views

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Abstracted Scientific Content

Published on 20 February 2015

Generics and off-patent biologicals for cancer treatment in developing countries

Submitted: 11 February 2015; Revised: 14 February 2015; Accepted: 15 February 2015; Published online first: 20 February 2015 Cancer represents a significant, and growing, burden on healthcare systems around the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.012

5.835 views

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Regulatory

Published on 06 February 2015

Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

Abstract: Biologicals have offered a new avenue for targeting therapy to treat life-threatening and chronic diseases. The recent or pending patent expirations of many successful biologicals have permitted the marketing...

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Ally Pen, PhD

biologicals, biosimilars, clinical trials, extrapolation, immunogenicity, regulatory

DOI: 10.5639/gabij.2015.0401.009

13.104 views

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Published on 30 January 2015

Generics authorization – groundbreaking regulatory approach to closer international cooperation on the rise – IGDRP

Submitted: 24 January 2015; Revised: not applicable; Accepted: 27 January 2015; Published online first: 30 January 2015 The ‘International Generic Drug Regulators Pilot’ (IGDRP) seems to be a true model...

Author(s): Christoph Baumgärtel, MD, MSc, DI Dr Katharina Gazda-Pleban

DOI: 10.5639/gabij.2015.0401.011

7.441 views

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Published on 29 January 2015

2014/4 GaBI Journal Table of Contents

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s third volume Editorial Availability and procurement of generics in hospitals among medium-sized European countries Letters to the Editor Access to...

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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

3.816 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

22.414 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

32.420 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

10.359 views

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