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

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…

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

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 2014. Ms Arpah Abas, Malaysia Dr Christoph Baumgärtel, Austria Professor Daniel Kelly Benjamin Jr, USA Professor Gerrit Borchard, Switzerland Dr Chiann Chang, Brazil…

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

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…

Abstract:This paper examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings (Sawai GHD) and other manufacturers. It provides a comprehensive analysis of the consequences stemming from lapses in good manufacturing practice (GMP) compliance, particularly highlighted by the case of teprenone capsules 50 mg…

Author(s): Takanao Hashimoto, PhD, Akihiko Ozaki, MD, PhD, Hiroaki Saito, MD, Erika Yamashita, Tetsuya Tanimoto, MD, Professor Mihajlo Jakovljevic, MD, PhD, MAE

COVID-19 pandemic, drug shortages, generic drugs, good manufacturing practice, pharmaceutical policy

DOI: 10.5639/gabij.2024.1303.036

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