Editor's Letter

Published on 24 March 2020

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

The current coronavirus pandemic raises some important questions relevant to generic and/or biosimilar products. While still unproven, there are some indications that approved antiviral compounds exist which might be able to decrease coronavirus associated morbidity and mortality. It is also possible that antibody products could be effective. It is not clear however whether/how governments will…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0901.001

Editor's Letter

Published on 22 September 2020

Latest features in GaBI Journal, 2020, Issue 3

The Commentary in this issue of the GaBI Journal by Dr Elwyn Griffiths discusses the need for more global harmonization of regulatory approaches to biological medicines. Dr Griffiths refers to the conclusions of the GaBI organized ASEAN (Association of Southeast Asian Nation) conference on this topic. Similar calls have however come from participants in other…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0903.016

Abstract: The US Food and Drug Administration (FDA) proposed eliminating the distinction between biosimilars and interchangeable biosimilars with the stated aim of aligning with European policy and enhance biosimilar uptake. However, this move is misguided as it would result in widespread generic-style automatic substitution at the pharmacy level; which is rare in Europe. Physician confidence…

Author(s): Michael S Reilly, Esq

formulary, interchangeable biosimilar, market uptake, pharmacy benefit managers

DOI: 10.5639/gabij.2024.1301.006

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 2015. Professor Saleh Alsuwayeh, Saudi Arabia Professor Moses Chow, USA Associate Professor Joshua P Cohen, USA Professor Theodor Dingermann, Germany Dr Niklas Ekman, Finland…

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory…

DOI: 10.5639/gabij.2021.1003.015

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 2019. Dr Chiann Chang, Brazil Professor Moses SS Chow, USA Dr Brian Godman, UK Professor Alan Lyles, USA Dr Robin Thorpe, UK Dr Marco…

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…

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…

Editor's Letter

Published on 25 November 2019

Latest features in GaBI Journal, 2019, Issue 3

Patients, their families and providers are facing increasing pressures related to the rapidly expanding global inequality which affects access to all components of a long, healthy, productive life including water, food, shelter, medical care, education, a free press, stable government and freedom from both natural and man-made threats including genocide and war. Attempts to increase…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2019.0803.011

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…

Editor's Letter

Published on 02 July 2020

What to look forward to in GaBI Journal, 2020, Issue 2

This issue of the GaBI Journal is being published as the global coronavirus 2 (SARS-CoV-2) pandemic is expanding rapidly in many areas of the world including in the United States of America, South America, Asia, and Africa. While there is no known effective vaccine or cure, preliminary results have suggested that some treatments approved for…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0902.008

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