Articles

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

17.678 views

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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

9.171 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 data, savings, value for money

DOI: 10.5639/gabij.2016.0503.027

7.052 views

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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 drugs, generic medicines, interchangeability, switchability

DOI: 10.5639/gabij.2016.0502.014

7.678 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

7.246 views

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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

13.355 views

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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...

2.850 views

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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...

2.426 views

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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...

2.484 views

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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...

2.539 views

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Thank you to reviewers

Published on 30 May 2016

Thank you to reviewers 2012

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...

2.575 views

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Review Article

Published on 04 May 2016

Assessment of the interchangeability between generics

Author byline as per print journal: Luther Gwaza1,2, BPharm, MPhil; John Gordon3, PhD; Henrike Potthast4, PhD; Marc Maliepaard5, PhD; Jan Welink5, Hubert Leufkens1,5, PhD; Matthias Stahl6, MD; Alfredo García-Arieta7, PhD...

Author(s): Alfredo García Arieta, PhD, Henrike Potthast, PhD, Hubert Leufkens, PhD, Jan Welink, John Gordon, PhD, Luther Gwaza, BPharm, MPhil, Marc Maliepaard, PhD, Matthias Stahl, MD

adjusted indirect comparisons, bioequivalence, drug switching, generic medicines, interchangeability, prequalification

DOI: 10.5639/gabij.2016.0502.015

12.570 views

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