Articles

Editor's Letter

Published on 04 July 2016

What to look forward to in GaBI Journal, 2016, Issue 2

This second issue of 2016 includes manuscripts that cover a number of important issues of interest to GaBI Journal including methods used to assess bioequivalence and decide on interchangeability, patient and...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0502.013

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Review Article

Published on 04 July 2016

The generic medicines system in Italy: scenarios for sustainable growth

Author byline as per print journal: Federico Fontolan1, MA; Silvia Zucconi1, MStat; Carlo Piccinni2, PhD Abstract: In this paper, an overview is provided of the present Italian generic medicines system....

Author(s): Carlo Piccinni, PhD, Federico Fontolan, MA, Silvia Zucconi, MStat

economic sustainability, generic medicines, manufacturing provision, pharmacoeconomics

DOI: 10.5639/gabij.2016.0503.029

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Perspective

Published on 29 June 2016

Importance of manufacturing consistency of the glycosylated monoclonal antibody adalimumab (Humira®) and potential impact on the clinical use of biosimilars

Author byline as per print journal: Professor Paul J Declerck, PhD; Paul W Tebbey, PhD Abstract: The clinical performance of biological therapies is affected by their manufacturing processes. The advent...

Author(s): Paul W Tebbey, PhD, Professor Paul J Declerck, PhD

adalimumab, biosimilar pharmaceuticals, consistency, glycosylation, immunogenicity, manufacturing

DOI: 10.5639/gabij.2016.0502.018

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Meeting Report

Published on 29 June 2016

Reducing healthcare costs and building trust in biosimilar medicines

Author byline as per print journal: Niklas Ekman, PhD; Professor Arnold G Vulto, PharmD, PhD; Paul Cornes, MD Abstract: The increasing cost of medicines was highlighted at the Biosimilar Medicines...

Author(s): Niklas Ekman, PhD, Paul Cornes, MD, Professor Arnold G Vulto, PharmD, PhD, FCP

biological, biosimilar, cancer, European Union, healthcare costs, medicines, regulatory

DOI: 10.5639/gabij.2016.0502.020

9.068 views

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Commentary

Published on 29 June 2016

Biosimilars: achieving long-term savings and competitive markets

Author byline as per print journal: Jorge Mestre-Ferrandiz, PhD; Adrian Towse, MA; Mikel Berdud, PhD Abstract: Payers need to think strategically in medium/long term to maximize benefits from biosimilars. Concerns...

Author(s): Adrian Towse, MA, Jorge Mestre-Ferrandiz, PhD, Mikel Berdud, PhD

biosimilars, competition, incentives, real world outcomes, savings, value for money

DOI: 10.5639/gabij.2016.0503.027

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Editorial

Published on 29 June 2016

Adjusted indirect comparisons between generics – bioequivalence and interchangeability

Abstract: Adjusted indirect comparisons are valuable to establish the bioequivalence and thereby the interchangeability between generic drug products. Limitations should be observed especially when several generics of a drug are...

Author(s): Professor Laszlo Endrenyi, PhD, DSc, Professor László Tóthfalusi, MSc, PhD

adjusted indirect comparisons, bioequivalence, generic medicines, interchangeability, multiple generic products, switchability

DOI: 10.5639/gabij.2016.0502.014

7.624 views

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Pharma News

Published on 27 June 2016

The anti-TNF biosimilar CT-P13 had comparable efficacy to infliximab in rheumatoid arthritis over one year

Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 The introduction of biologicals has revolutionized the treatment of immune-mediated diseases such...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.024

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Pharma News

Published on 27 June 2016

Switching from the infliximab reference product to CT-P13 in patients with rheumatoid arthritis or ankylosing spondylitis: results of the PLANETAS and PLANETRA extension studies

Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 CT-P13, also known by its brand names Remsima or Inflectra, is a...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.023

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Published on 08 June 2016

2016/1 GaBI Journal Table of Contents

Contents Editor’s Letter Editor’s introduction to the initial issue of the fifth volume of GaBI Journal Letters to the Editor First biosimilar of infliximab approved in Brazil: response from the...

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Thank you to reviewers

Published on 30 May 2016

Thank you to reviewers 2015

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI...

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Thank you to reviewers

Published on 30 May 2016

Thank you to reviewers 2014

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal...

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Thank you to reviewers

Published on 30 May 2016

Thank you to reviewers 2013

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal...

2.534 views

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