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

Author byline as per print journal: Esteban Ortiz-Prado1,2, MD, MSc, MPH, PhD; Jorge Ponce-Zea3, MSc; Jorge E Vasconez1, MD; Diana Castillo,1, MD; Diana C Checa-Jaramillo1, MD; Nathalia Rodrí­guez-Burneo1, MD; Felipe Andrade2, MD; Damaris P Intriago-Baldeón4, MSc; Claudio Galarza-Maldonado5, MD, PhD Abstract: The number of approved biological medicines in the global pharmaceutical market has increased in…

biologicals, biopharmaceuticals, biosimilars, Latin America

DOI: 10.5639/gabij.2020.0902.011

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Associate Professor Sia Ming Kian, BSc (Pharm) (Hons); Chan Lai Wah, BSc (Pharm) (Hons), PhD Abstract: Biopharmaceuticals belong to a class of medicinal products whose active pharmaceutical ingredient (API) is manufactured using living systems such as microbial and mammalian cells.…

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Sia Ming Kian, BSc (Pharm) (Hons)

ASEAN, biopharmaceutical manufacturing, biopharmaceuticals, good manufacturing practice, harmonization, regulatory guidelines

DOI: 10.5639/gabij.2020.0902.010

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

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

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

Abstract: As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in quality, preclinical and clinical tests. It is by these means that biosimilars are considered to be safe and efficacious. In India, any major deviation(s) from science-based principles in the manufacturing of a recombinant DNA-derived therapeutic biological product leads to…

Author(s): GR Soni, PhD

biosimilar, CDSCO, Innovator Reference Biological Product, non-innovator biologic, RCGM

DOI: 10.5639/gabij.2020.0901.006

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: 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

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

Author byline as per print journal: Shon Crampton1, BA; Alla Polozova1, PhD; Darin Asbury2, BS; Alexis Lueras2, BS; Paul Breslin1, BS; Jane Hippenmeyer3, PharmD; Jennifer Litowski1, PhD; Monica Goss2, PhD Study objectives: To investigate the quality and in-use stability of diluted ABP 980 (a trastuzumab biosimilar) versus reference trastuzumab to mimic dosing in intravenous (IV)…

ABP 980, biosimilar, stability, trastuzumab

DOI: 10.5639/gabij.2020.0901.002

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