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 they use them? Original Research Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients Review Article Biosimilar…

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

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…

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 2020. Dr Adel AL Harf, Saudi Arabia Professor Alain Astier, France Professor Moses SS Chow, USA Dr Alessandro Curto, Italy Professor Theodor…

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 2012. Ms Arpah Abas, Malaysia Dr Ibrahim Alshwaier, Saudi Arabia Professor Saleh Alsuwayeh, Saudi Arabia Dr Christoph Baumgärtel, Austria Professor Daniel Benjamin, USA…

Contents Editor’s Letter Latest features in GaBI Journal, 2017, Issue 3 Commentary Patent expiry and costs for anti­cancer medicines for clinical use Original Research A survey of Australian prescribers’ views on the naming and substitution of biologicals Review Article Biosimilars in Italy: what do real-world data reveal? Special Report Physician associations comment on FDA’s interchangeability…

Contents Editor’s Letter Latest features in GaBI Journal, 2016, Issue 3 Letters to the Editor Is the EU ready for non-biological complex drug products? Commentary Biosimilars: achieving long-term savings and competitive markets Review Article Current state of subsequent entry biologics (biosimilars) in Canada: a view from regulatory, reimbursement, clinician, and patient perspectives The generic medicines…

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…

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 2013. Dr Ibrahim Aljuffali, Saudi Arabia Professor Saleh Alsuwayeh, Saudi Arabia Professor Alain Astier, France Dr Christoph Baumgärtel, Austria Professor Mohamed Izham Bin…

Review Article

Published on 18 November 2024

A review of international initiatives on pharmaceutical regulatory reliance and recognition

Abstract: In light of recent global health challenges, the need for regulatory reliance – where one regulatory authority accepts the decisions of another – has gained significant interest and momentum. A fundamental role of any government is to protect its citizens and promote a healthy lifestyle by ensuring the quality, safety, and efficacy of medical…

Author(s): Vimal Sachdeva, MSc

authorization, best practice, harmonization, pharmaceuticals, recognition

DOI: 10.5639/gabij.2024.1303.034

Contents Editor’s Letter What to look forward to in GaBI Journal, 2017, Issue 2 Editorial Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond Commentary Strategies for pricing of pharmaceuticals and generics in developing countries Original Research What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results…

Contents Editor’s Letter Latest features in GaBI Journal, 2019, Issue 3 Commentary Ever-changing landscape of biosimilars in Canada; findings and implications from a global perspective Original Research Pharmacy chain drives choice among manufacturers of generic drugs in the US Medicare population Review Article An ever-evolving landscape: an update on the rapidly changing regulation and reimbursement…