Articles


Published on 07 July 2016

2016/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2016, Issue 2 Editorial Adjusted indirect comparisons between generics – bioequivalence and interchangeability Review Article Assessment of the interchangeability...

2.902 views

Abstracted Scientific Content

Published on 06 July 2016

Investigating the validity of biosimilar extrapolation and interchangeability

Submitted: 30 June 2016; Revised: 1 July 2016; Accepted: 1 July 2016; Published online first: 4 July 2016 The European Medicines Agency’s (EMA) decision to approve the use of CPT-13,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.022


7.532 views

Perspective

Published on 06 July 2016

Pharmacovigilance on biologicals and biosimilars: a Danish perspective

Abstract: The development of biological medicinal products is in rapid growth and as patents for reference products expire, new biosimilar products become available. This has a marked impact on several...

Author(s): Benedicte Lunddahl, DVM

biological medicinal products, biosimilars, national competent authority, pharmacovigilance

DOI: 10.5639/gabij.2016.0503.030


10.720 views

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


3.961 views

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


14.317 views

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


17.517 views

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


9.110 views

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


6.995 views

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


7.646 views

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


7.219 views

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


13.325 views

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...

2.843 views