Articles

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

23.799 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...

2.652 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...

2.992 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

9.026 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

3.024 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

8.860 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

12.732 views

Read more →

Letters to the Editor

Published on 14 December 2017

Comment on the non-biological complex drugs paper

Abstract: Comment on the Special Report by Professor Gerrit Borchard: Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias, published in GaBI Journal, 2016;5(1):36-41. Submitted: 3 November 2017; Revised: 13...

Author(s): Karthik Bodhinathan, PhD, MSM

Glatiramer acetate, multiple sclerosis, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2017.0604.032

5.412 views

Read more →

Commentary

Published on 14 December 2017

Global policies on pharmacy-mediated substitution of biosimilars: a summary

Abstract: An extensive overview of policies related to pharmacy-mediated substitution of biosimilars across the world was carried out by Larkin et al. in 2017. The details of this are discussed...

Author(s): Thijs J Giezen, PharmD, PhD, MSc

biosimilar, policy, regulation, substitution, switching

DOI: 10.5639/gabij.2017.0604.033

6.804 views

Read more →

Review Article

Published on 16 November 2017

Major lessons learned from Zarxio’s US launch: the start of a biosimilar revolution

Introduction: Launched in 2015, Zarxio™ (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval. In contrast, the first biosimilar was launched in Europe in 2006....

Author(s): Michael Sarshad, BSc, MBA

biosimilar, US Food and Drug Administration (FDA), Zarxio

DOI: 10.5639/gabij.2017.0604.035

23.535 views

Read more →

Meeting Report

Published on 13 November 2017

Perspectives on the future of pegfilgrastim biosimilars

Author byline as per print journal: Professor Pere Gascón, MD; Ruediger Jankowsky, PhD; Karsten Roth, PhD Abstract: Cinfa Biotech, the biosimilars specialists of the Cinfa Group, reviewed pegfilgrastim biosimilar approaches to...

Author(s): Karsten Roth, PhD, Professor Pere Gascón, MD, Ruediger Jankowsky, PhD

biosimilars, biotech, G-CSF, neutropenia, pegfilgrastim

DOI: 10.5639/gabij.2017.0604.040

13.126 views

Read more →

Special Report

Published on 13 November 2017

Building stakeholder confidence in biosimilar medicines through evidence-based information sharing

Abstract: The European Commission held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines provided an update of the...

Author(s): Assistant Professor Gianluca Trifirò, MD, PhD

best practice, biosimilar, interchangeability, pharmacovigilance, switching

DOI: 10.5639/gabij.2017.0604.038

5.380 views

Read more →