Articles

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Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper.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

6.565 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

13.154 views

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Commentary

Published on 31 March 2017

Patent expiry and costs for anti­cancer medicines for clinical use

Author byline as per print journal: Brian Godman, BSc, PhD; Claudia Wild, PhD; Alan Haycox, PhD Abstract: Venkatesan S et al. have researched patent rights and pricing for (non-)tyrosine kinase inhibitors....

Author(s): Alan Haycox, PhD, Brian Godman, BSc, PhD, Claudia Wild, PhD

cancer medicines, generics, health gain, prices, tyrosine kinase inhibitors

DOI: 10.5639/gabij.2017.0603.021

11.212 views

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Editor's Letter

Published on 27 September 2017

Latest features in GaBI Journal, 2017, Issue 3

It is clear that greater use of generics and biosimilars could greatly decrease healthcare costs and thereby increase availability of important medicines. It is equally clear that these potential savings...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0603.020

3.257 views

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Abstracted Scientific Content

Published on 01 February 2017

Effective generics substitution

Submitted: 19 January 2017; Revised: 20 January 2017; Accepted: 23 January 2017; Published online first: 6 February 2017 In an article published in US Pharmacist [1] Manigault et al. emphasize...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0602.019

5.077 views

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Abstracted Scientific Content

Published on 21 April 2017

Generic prices estimated for four novel cancer drugs

Submitted: 13 March 2017; Revised: 15 March 2017; Accepted: 16 March 2017; Published online first: 29 March 2017 Generic drug manufacturing of four major cancer drugs could massively reduce their...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0602.018

6.533 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

12.792 views

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Special Report

Published on 14 December 2016

Overview of the patent expiry of (non-)tyrosine kinase inhibitors approved for clinical use in the EU and the US

Author byline as per print journal: Subramanian Venkatesan, MSc; Associate Professor Martine Lamfers, PhD; Professor Sieger Leenstra, MD, PhD; Professor Arnold G Vulto, PharmD, PhD, FCP Abstract: Kinase inhibitors form the...

Author(s): Associate Professor Martine Lamfers, PhD, Professor Arnold G Vulto, PharmD, PhD, FCP, Professor Sieger Leenstra, MD, PhD, Subramanian Venkatesan, MSc

anticancer drugs, kinase inhibitors, market exclusivity, patent expiry, targeted therapies

DOI: 10.5639/gabij.2017.0602.016

58.841 views

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Original Research

Published on 31 March 2017

Do pricing and usage-enhancing policies differ between biosimilars and generics? Findings from an international survey

Introduction/Study objective: This paper aims to survey the policies implemented by European countries for pricing and promoting the use of biosimilar medicines and to explore similarities and differences with policies...

Author(s): Peter Schneider, MA, Sabine Vogler, PhD

biosimilar, generic, policy, pricing, substitution, tender

DOI: 10.5639/gabij.2017.0602.015

15.746 views

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Original Research

Published on 10 March 2017

What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

Author byline as per print journal: Jean-Baptiste Reiland, MSc; Barbara Freischem; Alexander Roediger, MA Introduction/Study objective Biosimilar policies with a focus on uptake have received a lot of attention at national...

Author(s): Alexander Roediger, MA, Executive MBA, Barbara Freischem, Jean-Baptiste Reiland, MSc

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

DOI: 10.5639/gabij.2017.0602.014

48.603 views

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Commentary

Published on 26 April 2017

Strategies for pricing of pharmaceuticals and generics in developing countries

Abstract: Dr Brian Godman and Professor Mohamed Azmi Hassali review Rida et al. regarding pricing strategies for pharmaceuticals in developing countries. Submitted: 15 March 2017; Revised: 22 March 2017; Accepted:...

Author(s): Brian Godman, BSc, PhD, Professor Mohamed Azmi Hassali, PhD

developing countries, generics, pharmaceutical pricing policy

DOI: 10.5639/gabij.2017.0602.013

10.067 views

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