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 2018. Professor Othman Alshabanah, Saudi Arabia Dr Ahmet Bosnak, Turkey Professor Moses SS Chow, USA Professor Theodor Dingermann, Germany Professor Jaime Espin,…

Contents Editor’s Letter Unmet potential of Generics and Biosimilars to reduce healthcare costs Original Research Pricing of oral generic cancer medicines in 25 European countries; findings and implications Review Article Are there biosimilar orphan drugs for Gaucher disease? An overview in Mexico Meeting Report 2nd MENA Stakeholder Meeting on Biosimilars 2018 – Report Abstracted Scientific…

Author byline as per print journal: Professor Philip J Schneider1, MS, FASHP, FASPEN, FFIP; Michael S Reilly2, Esq Abstract: Approximately 25% of all new medicines approved in recent years and in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory and payer requirements, combined with the needs…

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP

biologicals/biosimilars, competition, patients, procurement, substitution, sustainability

DOI: 10.5639/gabij.2020.0902.013

Editor's Letter

Published on 14 August 2019

Unmet potential of Generics and Biosimilars to reduce healthcare costs

The high cost of pharmaceuticals has been gaining increasing attention as a threat to both healthcare systems and patients’ access to care globally. This GaBI issue contains articles focusing on the fact that generics and follow-on biologicals have yet to achieve their potential to mitigate these costs in most if not all countries. In an…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2019.0802.006

Contents Editor’s Letter Editor’s introduction to the initial issue of the eighth volume of GaBI Journal Legal Biosimilars: considerations in light of the Italian legal framework Special Report Patent expiry dates for biologicals: 2018 update Pharma News Top developments in biosimilars during 2018 Abstracted Scientific Content Regulatory requirements for the acceptance of foreign comparator products…

Editor's Letter

Published on 29 May 2019

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

This issue contains important information and manuscripts, but the small number of original papers illustrates the challenge the GaBI Journal (as well as many other legitimate journals) is having attracting quality work. This challenge may at least in part be the result of the rapid growth of medical journals. There are now tens of thousands…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2019.0801.001

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