Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Introduction: In the United States (US), a legal framework for approving biosimilars was established via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). At the time of writing (September 2022), 38 biosimilars have been approved…

biosimilars, interchangeability, substitution, switching, US

DOI: 10.5639/gabij.2022.1103.016

Editor's Letter

Published on 30 September 2013

Latest features in GaBI Journal, 2013, Issue 3

The GaBI Journal again contains manuscripts covering a wide range of pertinent topics. In an Editorial, Dr Gianluigi Casadei reviews Italy’s final position paper on biosimilars including the new price and reimbursement position from the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA). Dr Casadei questions how much of a ‘step forward’ as well as…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0203.032

Submitted: 22 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 2023 Biologics are the fastest-growing class of medications in the United States and account for a substantial and growing portion of healthcare costs. The Biologics Price Competition Act of 2009 created an abbreviated approval pathway for the U.S. Food…

Author(s): Sarah Schrieber, PharmD

DOI: 10.5639/gabij.2023.1203.016

Editor's Letter

Published on 18 March 2014

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

This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their implementation in some Latin American countries. Three Original Research papers describe real life clinical examples relating to the use and evaluation of follow-on products respectively;…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0301.001

Sponsored Article

Published on 14 September 2023

Biosimilar antibody drug conjugates: considerations of higher order structure and aggregation

Abstract: Undoubtedly the complexity of antibody drug conjugate (ADC) molecules where three components (monoclonal antibody, cytotoxic drug and appropriate linker) are involved poses a challenge for biosimilar development. As with all biomolecule development, both novel and biosimilar, it is important to choose orthogonal analytical techniques to interrogate Quality Attributes, particularly for higher order structure (HOS)…

Author(s): Richard L Easton, BSC (Hons), DIC, PhD

antibody-drug conjugates, biosimilarity, characterization techniques, higher order structure, orthogonality, protein aggregation

DOI: 10.5639/gabij.2023.1203.018

Submitted: 13 September 2017; Revised: 17 September 2017; Accepted: 18 September 2017; Published online first: 25 September 2017 Both pharmacists and doctors in Guatemala lack trust in generic medicines, according to a study carried out by a local non-governmental organization (NGO) [1]. The authors make recommendations for increasing generics uptake, including changing dispensing practices and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0603.028

Submitted: 21 November 2016; Revised: 22 November 2016; Accepted: 24 November 2016; Published online first: 30 November 2016 Authors from the IRCCS – Istituto di Ricerche Farmacologiche ‘Mario Negri’, Milan, Italy discuss some of the most frequent concerns raised by internists (doctors of internal medicine) about biosimilars [1]. They also try to explain the scientific…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.049

Abstract: While Americans are deeply concerned about drug prices, the United States Trade Representative (USTR) continues to negotiate agreements like the United States-Mexico-Canada Agreement (USMCA) that put at risk the sustainability of the generics industry and undermine the development of biosimilars that play a critical role in access to medicines. It is time to restore…

Author(s): Maria Fabiana Jorge, MBA

access to medicines, biosimilars, generic drugs, trade agreements, USMCA

DOI: 10.5639/gabij.2020.0901.005

Submitted: 1 December 2016; Revised: 6 December 2016; Accepted: 7 December 2016; Published online first: 12 December 2016 In Sweden, the government funds an insurance programme covering 75–80% of the cost of prescription drugs for patients. Since 2002, in an attempt to contain costs, pharmacists have had to inform consumers whether less expensive substitute products…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.050

Abstract: This article explains what motivated the Digestive Cancers Europe’s (DiCE) recent position paper on biosimilar medicines for colorectal cancer. Submitted: 7 October 2019; Revised: 14 October 2019; Accepted: 15 October 2019; Published online first: 25 October 2019 Background Colorectal cancer may not be as widely known or talked about as some other types of…

Author(s): Zorana Maravic, BSc, MBA

biosimilars, colorectal cancer, digestive cancers, patients, position paper

DOI: 10.5639/gabij.2019.0803.017

Original Research

Published on 28 November 2023

Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software

Author byline as per print journal: Dhananjay Panigrahi1, MPharm; Aditya Murthy2, MPharm, PhD; Shubham Jamdade2, MPharm; Manoj Gundeti2, MPharm; Nagarjun Rangaraj1, MPharm, PhD; Anup Avijit Choudhury1, MPharm; Tausif Ahmed2, MPharm, PhD; Venkat Ramana Naidu1, MPharm, PhD Introduction: In this work, we present model` guided development of a new Etoricoxib tablet formulation using a proprietary technology.…

etoricoxib, GastroPlus®, modelling and simulation, PBBM, spray granulation, virtual bioequivalence

DOI: 10.5639/gabij.2024.1301.003

Editor's Letter

Published on 04 July 2016

What to look forward to in GaBI Journal, 2016, Issue 2

This second issue of 2016 includes manuscripts that cover a number of important issues of interest to GaBI Journal including methods used to assess bioequivalence and decide on interchangeability, patient and advocacy group opinions concerning the use of follow-on products, batch-to-batch consistency in monoclonal antibody production, and the causes and potential ways to deal with the…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0502.013