Submitted: 4 March 2019; Revised: 25 April 2019; Accepted: 27 April 2019; Published online first: 30 April 2019 The availability of quality generic drug products plays an increasingly important role in promoting access to medicines worldwide and in helping to address rising healthcare costs. This, however, has led to significant pressures on medicines regulatory authorities…

Author(s): Alfredo García Arieta, PhD

DOI: 10.5639/gabij.2019.0801.005

Submitted: 5 February 2019; Revised: 14 March 2019; Accepted: 20 March 2019; Published online first: 2 April 2019 The global market for biosimilars is valued at approximately US$4 billion, and it is growing rapidly as patents expire on an increasing number of biological drugs. A number of important milestones were achieved during 2018 regarding approval…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2019.0801.004

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s seventh volume Editorial Nomenclature for biosimilars; a continuing thorny issue Original Research Ongoing activities to influence the prescribing of proton pump inhibitors within the Scottish National Health Service: their effect and implications Review Article The need for distinct nomenclature for originator and biosimilar products Meeting…

Editor's Letter

Published on 28 January 2019

Fourth and final issue of GaBI Journal’s seventh volume

Globalization of the world’s economy has clearly created both major advances and ongoing challenges including in the pharmaceutical industry. Naming of pharmaceuticals might seem to be an uninteresting topic to those outside of the pharmaceutical industry. In fact, as I learned many years ago as a volunteer member of the US Pharmacopeia (USP) Nomenclature Committee,…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0704.028

Contents Editor’s Letter Latest features in GaBI Journal, 2018, Issue 3 Commentary Medicines regulation in the MENA region and the importance of the World Health Organization’s INN proposal of Biological Qualifier Original Research Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures Implementing…

Submitted: 6 December 2018; Revised: 12 December 2018; Accepted: 14 December 2018; Published online first: 19 December 2018 Generic drugs are currently central to disease treatment in the US. However, recent policy concerns have focussed on generics supply inadequacies and the perceived increase in prices of some generic drug products. To further explore the changing…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0704.033

Submitted: 21 November 2018; Revised: 22 November 2018; Accepted: 28 November 2018; Published online first: 4 December 2018 A study published by the World Health Organization (WHO) compares the effect of different pricing policies for generic medicines in four countries [1]. Using atorvastatin as a case study, their results show that price cuts combined with…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0703.027

Editor's Letter

Published on 03 December 2018

Latest features in GaBI Journal, 2018, Issue 3

This third issue of GaBI Journal in 2018 contains manuscripts which discuss a number of important, post-marketing, ‘real world’ generic and biosimilar medicinal product issues. In a Commentary, Pitts and Reilly discuss why they believe that unique product names are needed for both generics and biosimilar medicinal products. They discuss the need for consideration of…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0703.020

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 Journal) in 2017. Professor Daan JA Crommelin, The Netherlands Dr Alessandro Curto, Italy Professor Francisco Jose de Abajo Iglesias, Spain Professor Theodor Dingermann, Germany…

Contents Editor’s Letter What to look forward to in GaBI Journal, 2018, Issue 2 Commentary Potential changes to the FDA approach to biosimilars have a global impact Original Research Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2 Review Article Protein heterogeneity and…

Editor's Letter

Published on 27 August 2018

What to look forward to in GaBI Journal, 2018, Issue 2

The second issue of the 2018 GaBI Journal volume is being published at a time of increasing uncertainty concerning trade, tariffs, regulations as well as international and even inter-ally co-operation. This issue contains manuscripts discussing some changes which are either being asked for, or which are already occurring, with the potential to increase the global…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0702.010

Submitted: 20 June 2018; Revised: 14 August 2018; Accepted: 18 August 2018; Published online first: 31 August 2018 The ageing population, longer life expectancies, and the increasing cost of drugs are expected to significantly increase the burden on healthcare systems in the coming years. To reduce this burden and increase access to new, innovative and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0703.026