Articles

Review Article

Published on 19 January 2018

The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US

Author byline as per print journal: Hajaj M Alhomaidan; Ali M Alhomaidan, PhD Abstract: This paper describes the differences in human embryonic stem cell regulations in several Christian countries across...

Author(s): Ali M Alhomaidan, PhD, Hajaj M Alhomaidan

regulation, religion, stem cell

DOI: 10.5639/gabij.2018.0701.005

23.382 views

Read more →

Meeting Report

Published on 19 January 2018

Quality assessment of biosimilars in Colombia – reducing knowledge gaps

Abstract: Biosimilar medicines are having a global effect, and as such regulatory agencies worldwide are assessing how to respond to them. Here, two events held by GaBI for the Colombian...

Author(s): Elaine Gray, PhD, Paul Matejtschuk, PhD, CChem, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, Colombia, quality assessment, regulatory

DOI: 10.5639/gabij.2018.0702.017

7.265 views

Read more →

Regulatory

Published on 17 January 2018

Regulations for biotherapeutics approval in Colombia

Author byline as per print journal: Johanna Andrea García Cortes, MSc; Francisco Javier Sierra Esteban, MSc Abstract: Colombia is in the process of implementing legislation to allow for the approval...

Author(s): Francisco Javier Sierra Esteban, MSc, Johanna Andrea García Cortes, MSc

abbreviated comparability, biotherapeutics approval, Colombia, INVIMA

DOI: 10.5639/gabij.2018.0701.006

46.374 views

Read more →

Commentary

Published on 17 January 2018

EU Member States have tools to reduce costs of bestseller biologicals but can they use them?

Abstract: Major cost savings are achievable in pharmacotherapy in the European Union since biosimilars to most best-selling biological medicinal products have been licensed. Unfortunately, the window of opportunity may be...

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

automatic substitution, biosimilars, cost savings, interchangeability, payers, prescribers

DOI: 10.5639/gabij.2018.0701.002

12.486 views

Read more →

Editor's Letter

Published on 10 January 2018

Editor’s introduction to the initial issue of the seventh volume of GaBI Journal

There are many frustrating differences between reality and what is possible in every aspect of life, including politics, economics, science and health. This issue begins with a Commentary by Adjunct...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0701.001

3.025 views

Read more →

Original Research

Published on 09 January 2018

Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures

Author byline as per print journal: Victoire Vieillard, PharmD; Professor Alain Astier, PharmD, PhD; Muriel Paul, PharmD Objectives: This study assessed the long-term stability of the trastuzumab biosimilar CT-P6 (Herzuma®, Biogaran)...

Author(s): Muriel Paul, PharmD, Professor Alain Astier, PharmD, PhD, Victoire Vieillard, PharmD

biosimilar, extended stability, in-use stability, trastuzumab

DOI: 10.5639/gabij.2018.0703.022

23.371 views

Read more →

Published on 05 January 2018

2018/1 GaBI Journal Table of Contents

Contents Editor’s Letter Editor’s introduction to the initial issue of the seventh volume of GaBI Journal Commentary EU Member States have tools to reduce costs of bestseller biologicals but can...

2.635 views

Read more →

Published on 01 January 2018

2017/4 GaBI Journal Table of Contents

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s sixth volume Letters to the Editor Clear naming, traceability of biological medicines will protect patients Comment on the non-biological complex...

2.970 views

Read more →

Original Research

Published on 15 December 2017

Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2

Author byline as per print journal: Magaly Perez-Nieves1, MPH, PhD; Robyn K Pollom1, ANP; Ran Duan1, PhD; Samaneh Kabul1, PharmD; Amy M DeLozier1, MPH; Puneet Kaushik2, MPharm; Liza L Ilag1,...

Author(s): Amy M DeLozier, MPH, Liza L Ilag, MD, Magaly Perez-Nieves, MPH, PhD, Puneet Kaushik, MPharm, Ran Duan, PhD, Robyn K Pollom, ANP, Samaneh Kabul, PharmD

biosimilar, follow-on biological, glargine, patient-reported outcomes, type 1 diabetes mellitus, type 2 diabetes mellitus

DOI: 10.5639/gabij.2018.0702.012

8.964 views

Read more →

Editor's Letter

Published on 15 December 2017

Fourth and final issue of GaBI Journal’s sixth volume

Change is inevitable but often resisted, including or even especially in medicine. Hand washing is still neglected 170 years after Semmelweis’ work, misuse of antibiotics persists 72 years after Fleming...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0604.030

3.009 views

Read more →

Abstracted Scientific Content

Published on 14 December 2017

Randomized non-inferiority trial fails to find inferiority switching from infliximab originator to CT-P13 biosimilar

Submitted: 17 November 2017; Revised: 20 November 2017; Accepted: 22 November 2017; Published online first: 5 December 2017 The tumour necrosis factor (TNF) inhibitor infliximab is known to significantly improve...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.042

8.836 views

Read more →

Special Report

Published on 14 December 2017

USA and Europe differ in interchangeability of biosimilars

Abstract: This paper highlights differences between USA and Europe when it comes to the interchangeability of biosimilars. The lack of harmonization between USA and Europe may introduce confusion for stakeholders...

Author(s): GaBI Journal Editor

biosimilar, EMA, interchangeability

DOI: 10.5639/gabij.2017.0604.039

12.634 views

Read more →