Articles

Review Article

Published on 26 May 2020

Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals

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...

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

20.349 views

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Special Report

Published on 29 April 2020

Clinical trials for trastuzumab biosimilars

Abstract: Clinical trials must demonstrate biosimilarity for regulatory marketing approval to be granted. The GaBI Journal has conducted a search for clinical trials that have been, or are being, carried...

Author(s): GaBI Journal Editor

biosimilar, clinical trials, trastuzumab

DOI: 10.5639/gabij.2020.0902.014

5.059 views

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Meeting Report

Published on 25 March 2020

3rd Colombian educational workshop on regulatory assessment of biosimilars 2019 – Report

Author byline as per print journal: Professor John-Joseph Borg, PhD; Yolanda Elias Gramajo, MD; Professor Andrea Laslop, MD; Robin Thorpe, PhD, FRCPath; Jian Wang, MD, PhD Introduction: Biosimilars have the...

Author(s): Jian Wang, MD, PhD, Professor Andrea Laslop, MD, Professor John-Joseph Borg, Robin Thorpe, PhD, FRCPath, Yolanda Elias Gramajo, MD

biologicals, biosimilars, Colombia, INVIMA

DOI: 10.5639/gabij.2020.0903.022

8.703 views

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Regulatory

Published on 25 March 2020

Regulatory pathway for approval of ‘biosimilars’ in Iran

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...

Author(s): Jalal Naeli, MD

biopharmaceuticals, Iran, reference medicinal product

2.595 views

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Review Article

Published on 25 March 2020

Current trends for biosimilars in the Latin American market

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...

biologicals, biopharmaceuticals, biosimilars, Latin America

DOI: 10.5639/gabij.2020.0902.011

13.858 views

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Published on 24 March 2020

2020/1 GaBI Journal Table of Contents

Contents Editor’s Letter Editor’s introduction to the initial issue of the ninth volume of GaBI Journal Original Research Stability of the trastuzumab biosimilar ABP 980 compared to reference product after...

2.112 views

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Thank you to reviewers

Published on 24 March 2020

Thank you to reviewers 2019

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...

2.373 views

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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...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0901.001

2.467 views

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Commentary

Published on 18 March 2020

Importance of the determination of the higher order structure in the in-use stability studies of biopharmaceuticals

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...

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

analysis, biosimilar, protein, spectroscopy, structure

DOI: 10.5639/gabij.2020.0902.009

9.106 views

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Pharma News

Published on 18 March 2020

Top developments in biosimilars during 2019

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...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2020.0901.007

10.863 views

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Research News

Published on 27 February 2020

Poor traceability of biologicals in UK ADR reporting indicates the need for improvements to ensure patient safety

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...

Author(s): Kevin Klein, PhD

DOI: 10.5639/gabij.2020.0902.012

3.335 views

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Original Research

Published on 19 February 2020

Pharmaceutical pricing policy in Saudi Arabia: findings and implications

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...

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

23.916 views

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