Author byline as per print journal: Yuqi Li, BS Pharm; Shein-Chung Chow, PhD Abstract:  A biosimilar product is a biological product which is highly similar to an existing reference product in structure and function and has no clinically meaningful difference in terms of safety, purity or potency. Under the Biologics Price Competition and Innovation Act of…

biosimilars, interchangeability, logarithmic transformation, statistical evaluation

DOI: 10.5639/gabij.2022.1102.010

Contents Editor’s Letter What to look forward to in GaBI Journal, 2016, Issue 2 Editorial Adjusted indirect comparisons between generics – bioequivalence and interchangeability Review Article Assessment of the interchangeability between generics  Legal Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update Perspective New monoclonal antibody biosimilars approved…

Contents Editor’s Letter Editor’s introduction to the initial issue of the fifth volume of GaBI Journal Letters to the Editor First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society Commentary Low-cost generic drug programs in the US: implications for payers and researchers Waiver of consent for retrospective chart review studies Original…

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

Editor's Letter

Published on 12 June 2017

What to look forward to in GaBI Journal, 2017, Issue 2

The use both generics and biosimilars offers the potential to increase availability of medicines through decreases in cost that should occur when an expensive product (drug) loses patent protection and lower cost alternatives are marketed in countries with a ‘free-market’ economy. As the manuscripts in this issue of GaBI Journal emphasize, it is clear however…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0602.011

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

Abstract: Iran was the first country in the MENA (Middle East and North Africa) region to publish a legal framework for the registration of biosimilars. This framework is defined by the Iranian Food and Drug Administration (IFDA). It defines biosimilars as biological products that have the same Active Pharmaceutical Ingredient (API) as the Reference Medicinal…

Author(s): Jalal Naeli, MD

biopharmaceuticals, Iran, reference medicinal product

Abstract:US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the legal designation was first created in 2010. Based on experience, FDA now acknowledges that clinical switching studies are not generally needed for the interchangeability designation as quality, safety and efficacy are established by biosimilarity already. Approval pathways for biosimilars and interchangeable…

Author(s): Gillian R Woollett, MA, DPhil, Joseph P Park, PhD

biosimilars, BPCIA, interchangeability, market exclusivity, quality, switching

DOI: 10.5639/gabij.2024.1303.035

Editor's Letter

Published on 23 February 2021

First 2021 GaBI Journal issue highlights

The articles in this first issue contain a large volume of useful information on the global development, approval, manufacturing, marketing, and uptake of biosimilars. The first Original Research by Dr Hye-Na Kang et al. from the World Health Organization (WHO) presents an extensive listing of data on the status of approved similar biotherapeutic products. While,…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1001.001

Contents Editor’s Letter Editor’s introduction to the initial issue of the sixth volume of GaBI Journal Letters to the Editor Pricing strategies for pharmaceuticals in developing countries: what options do we have? Original Research Naming and labelling of biologicals – a survey of US physicians’ perspectives Review Article Ocular emulsions and dry eye: a case…

Submitted: 15 March 2021; Revised: 17 March 2021; Accepted: 18 March 2021; Published online first: 24 March 2021 Cancer is one of the leading causes of mortality in the world today. The development of new drugs can reduce death rates, but these products are extremely expensive in terms of development time and money. This has…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2021.1002.011

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…