Abstract: Knowledge of the higher order structure of proteins is important in biopharmacological studies, such as in biosimilar comparability studies. This paper describes the analytical methods available to determine higher order structures. It finds that, although other methods exist, spectroscopic methods remain most commonly used. Submitted: 7 February 2020; Revised: 7 March 2020; Accepted: 12…

Author(s): Professor Alain Astier, PharmD, PhD

analysis, biosimilar, protein, spectroscopy, structure

DOI: 10.5639/gabij.2020.0902.009

Submitted: 3 February 2020; Revised: 12 February 2020; Accepted: 18 February 2020; Published online first: 25 February 2020 2019 has been a busy year for biosimilars; there have been a record number of approvals and the start of many clinical trials. It has been a particularly busy year for the oncology and anti-inflammatory therapeutic areas, with…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2020.0901.007

Submitted: 27 January 2020; Revised: 29 January 2020; Accepted: 29 January 2020; Published online first: 25 February 2020 Biological medical products (biologicals) are derived from living cells or organisms. Due to their complex structures and the inherent challenges for manufacturing, a degree of minor variability may exist between different batches of the same product and between…

Author(s): Kevin Klein, PhD

DOI: 10.5639/gabij.2020.0902.012

Introduction: Many countries have introduced policies and strategies to limit pharmaceutical expenditures. These include pharmaceutical pricing policies and related strategies to control medicine prices and to ensure appropriate and stable prices. The aim of this study was to provide an overview of the current pharmaceutical pricing policy for medicines in Saudi Arabia and to provide…

Author(s): Alian A Alrasheedy, BPharm(Hons), MPharm(Clin), PhD, MACP, RPh

health expenditures, medicine prices, pharmaceutical expenditure, pharmaceutical policy, pricing, Saudi Arabia

DOI: 10.5639/gabij.2020.0901.003

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…

Abstract: Around the world, especially in low- and middle-income countries, national regulatory authorities are struggling with registration backlogs and the affordability of medicines. This paper draws on the example of cancer biosimilars in South Africa to illustrate how non-governmental organizations can help regulatory authorities decide which registration applications to prioritize by providing information on clinical…

Author(s): Paul Malherbe, PhD

biosimilars, non-governmental organizations, registration backlog, regulation

DOI: 10.5639/gabij.2020.0901.004

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

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

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

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 2018. Professor Othman Alshabanah, Saudi Arabia Dr Ahmet Bosnak, Turkey Professor Moses SS Chow, USA Professor Theodor Dingermann, Germany Professor Jaime Espin,…

Contents Editor’s Letter Unmet potential of Generics and Biosimilars to reduce healthcare costs Original Research Pricing of oral generic cancer medicines in 25 European countries; findings and implications Review Article Are there biosimilar orphan drugs for Gaucher disease? An overview in Mexico Meeting Report 2nd MENA Stakeholder Meeting on Biosimilars 2018 – Report Abstracted Scientific…

Author byline as per print journal: Professor Philip J Schneider1, MS, FASHP, FASPEN, FFIP; Michael S Reilly2, Esq Abstract: Approximately 25% of all new medicines approved in recent years and in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory and payer requirements, combined with the needs…

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP

biologicals/biosimilars, competition, patients, procurement, substitution, sustainability

DOI: 10.5639/gabij.2020.0902.013