Articles

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

12.971 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

60.514 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, generics, policy, pricing, substitution, tender

DOI: 10.5639/gabij.2017.0602.015

15.998 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

48.907 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

10.149 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

10.559 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

2.825 views

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Pharma News

Published on 10 February 2017

Top developments in biosimilars during 2016

Submitted: 27 January 2017; Revised: 31 January 2017; Accepted: 1 February 2017; Published online first: 6 February 2017 Previous years have been momentous for biosimilars [1] and 2016 is no...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0601.010

7.440 views

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Opinion

Published on 01 March 2017

Austrian medicines authority positive towards biosimilar interchangeability

Abstract: Clinical evidence supporting biosimilar use is growing and for the first time, the Austrian Medicines and Medical Devices Agency takes a positive position on interchangeability. They now state that...

Author(s): Christoph Baumgärtel, MD, MSc

Austria, biosimilars, interchangeability

DOI: 10.5639/gabij.2017.0601.009

9.555 views

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Meeting Report

Published on 14 December 2016

Biosimilar product labels in Europe: what information should they contain?

Abstract: In 2016, a multi-stakeholder workshop was held on the topic of ‘Biosimilar Labelling’. The discussions concerning labelling particulars are outlined in this meeting report. Submitted: 21 November 2016; Revised:...

Author(s): GaBI Journal Editor

biosimilar, labelling, patients, pharmacists, physicians, Summary of Product Characteristics (SmPC)

DOI: 10.5639/gabij.2017.0601.008

9.453 views

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Meeting Report

Published on 01 March 2017

Roundtable on biosimilars: pharmacovigilance, traceability, immunogenicity, 15 November 2016, Madrid, Spain

Author byline as per print journal: Professor Francisco José de Abajo, MD, MPH, PhD; Professor Joan Albanell, MD; Olga Delgado Sanchez, PharmD; Kevin Klein, MSc; José Vicente Moreno-Muelas, MD; Sol Ruiz, PhD; Professor...

Author(s): José Vicente Moreno-Muelas, MD, Kevin Klein, PhD, Olga Delgado Sanchez, PharmD, Professor Francisco José de Abajo, MD, MPH, PhD, Professor Francisco Zaragozá, PhD, Professor Joan Albanell, MD, Professor Maria Jesús Sanz Ferrando, PhD, Robin Thorpe, PhD, FRCPath, Sol Ruiz, PhD

biologicals, immunogenicity, interchangeability, pharmacovigilance, Spain, traceability

DOI: 10.5639/gabij.2017.0601.007

8.570 views

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Special Report

Published on 23 January 2017

Patent expiry dates for biologicals: 2016 update

Abstract: Biosimilars have been approved in Europe since 2006 and in the US since 2015. With patents on originator biologicals expiring and ever-tightening healthcare budgets, biosimilars are expected to take...

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2017.0601.006

27.114 views

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