Articles

Regulatory

Published on 28 May 2015

Update on US state legislation on biosimilars substitution

Abstract: Since the biosimilars pathway was introduced, many US states have been considering, or have introduced, legislation to allow for substitution of biosimilars deemed interchangeable. This paper gives an update...

Author(s): GaBI Journal Editor

biologicals, biosimilars, legislation, notification, substitution

DOI: 10.5639/gabij.2015.0402.020

9.314 views

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Perspective

Published on 28 May 2015

Norway, biosimilars in different funding systems. What works?

Abstract: Biosimilars can substitute treatment with expensive biological drugs and release money to treat more patients. Experience from Norway shows how this can be done with and without success. Submitted:...

Author(s): Asbjørn Mack, MD

biosimilars, discounts, market penetration, tender

DOI: 10.5639/gabij.2015.0402.018

18.857 views

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Original Research

Published on 17 April 2015

Product naming, pricing, and market uptake of biosimilars

Abstract: With a number of patents on biological medicines soon to expire in the US, multiple stakeholders – from policymakers to manufacturers to payers – have been debating the structure...

Author(s): Jacqueline Vanderpuye-Orgle, MSc, PhD, Joseph P Fuhr, PhD, Amitabh Chandra, PhD, John Romley, PhD, Tiffany Shih, PhD, Suepattra G May, MPH, PhD

biosimilar, market uptake, nomenclature, regulatory, specialty pharmaceuticals

DOI: 10.5639/gabij.2015.0402.015

22.192 views

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Published on 16 April 2015

2015/1 GaBI Journal Table of Contents

Contents Editor’s Letter Editor’s introduction to the initial issue of the fourth volume of GaBI Journal Editorial Biosimilars: patient and physician acceptability is the fifth hurdle to market competition Letters...

3.252 views

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Review Article

Published on 13 April 2015

Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future

Author byline as per print journal: Brian Godman, BSc, PhD; Michael Wilcock, MPharm; Andrew Martin, MPharm; Scott Bryson, MSc, MPH; Christoph Baumgärtel, MD; Tomasz Bochenek, MD, MPH, PhD; Winne de Bruyn, BSc;...

Author(s): Brian Godman, BSc, PhD, et al.

generics, health authorities, Lyrica, pregabalin

DOI: 10.5639/gabij.2015.0403.028

24.293 views

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Review Article

Published on 26 March 2015

The refinement of the super generic concept: semantic challenge for product re-innovation?

Background: Uptake of super generic or hybrid pharmaceuticals has decelerated despite their important economic potential for the generic pharmaceutical industry. The aim of switching to these product portfolios was to...

Author(s): Fereshteh Barei, PhD, Malcolm Ross

505(b)(2) approvals, generics, improved therapeutics, innovation, new therapeutics entities, super generics

DOI: 10.5639/gabij.2015.0401.007

82.528 views

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Editor's Letter

Published on 26 March 2015

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

This first 2015 GaBI Journal issue (fourth volume of the journal) is being published soon after the first US biosimilar approval and it contains a number of articles that illustrate...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0401.001

3.733 views

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Published on 26 March 2015

Online biosimilars resource for patients across Latin America

Submitted: 6 March 2015; Revised: 9 March 2015; Accepted: 10 March 2015; Published online first: 23 March 2015 A new online resource on biological and biosimilar medicines in Latin America...

Author(s): Ian Ford

DOI: 10.5639/gabij.2015.0402.021

5.219 views

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Special Report

Published on 26 March 2015

Generic medicines entry into the Malaysian pharmaceutical market

Author byline as per print journal: Omotayo Fatokun, PhD; Professor Mohamed Izham Mohamed Ibrahim, PhD; Professor Mohamed Azmi Hassali, PhD Abstract: There are major barriers to generic medicine development and market...

Author(s): Omotayo Fatokun, PhD, Professor Mohamed Azmi Hassali, PhD, Professor Mohamed Izham Mohamed Ibrahim, PhD

generic medicines, Malaysia, market entry, patent, pharmaceutical market

DOI: 10.5639/gabij.2016.0504.046

12.060 views

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Editorial

Published on 25 March 2015

Biosimilars: patient and physician acceptability is the fifth hurdle to market competition

Abstract: Biosimilar products confront novel market authorization and post-marketing use hurdles. Existing evidence is insufficient to fully address physician and payer acceptability thresholds. Submitted: 4 March 2015; Revised: 5 March...

Author(s): Professor Alan Lyles, BSPharm, MPH, ScD

acceptability, biologicals, biosimilars, interchangeability, pricing

DOI: 10.5639/gabij.2015.0401.002

8.719 views

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Meeting Report

Published on 25 March 2015

First Latin American educational workshop on similar biotherapeutic products, Mexico City, Mexico, 20 January 2015

Introduction: Similar Biotherapeutic Products (SBPs or biosimilars) comprise a rapidly expanding area of therapeutics worldwide. However, best practices for their regulation are lacking in many Latin American countries. Methods: The...

Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, follow-on drugs, Latin America, Mexico, regulatory practice

DOI: 10.5639/gabij.2015.0403.031

6.264 views

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