Articles

Special Report

Published on 11 June 2013

A progress report on the 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence

Author byline as per print journal: Jon SB de Vlieger1, PhD; Professor Daan JA Crommelin2, PhD; Beat Flühmann3, PhD; Professor Imre Klebovich4, PharmD, PhD, DSc; Professor Stefan Mühlebach3,5, PhD; Vinod...

Author(s): Beat Flühmann, PhD, Daan JA Crommelin, Imre Klebovich, Jon SB de Vlieger, PhD, Professor Stefan Mühlebach, PhD, Vinod P Shah, PhD

biological medicinal products, equivalence, nanomedicines, NBCD similar approach, NBCDs, non-biological complex drug (NBCD) products

DOI: 10.5639/gabij.2019.0803.016

10.253 views

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Commentary

Published on 30 September 2013

Maximizing quality in the manufacture of biologicals

Abstract: Biological product quality is susceptible to unexpected manufacturing issues, and the resulting variation may impact the safety or efficacy of these medicines and increase risks to patients. These risks...

Author(s): Gustavo Grampp, PhD, Sundar Ramanan, PhD

biologicals, manufacturing, quality, safety

DOI: 10.5639/gabij.2013.0204.049

10.220 views

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Original Research

Published on 16 December 2014

Payer and physician evidence and discount requirements for biosimilars in three Latin American countries

Study objectives: In Latin America, many governments have attempted to address biosimilar safety and efficacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores...

Author(s): André Vidal Pinheiro, PhD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Daniele Severi Bruni, MPhil, Ronald Halbert, MD, MPH, Erik Sandorff, MA, MBA

biosimilar pharmaceuticals, discounts, drug industry, Latin America, prescribing

DOI: 10.5639/gabij.2015.0401.005

10.185 views

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Commentary

Published on 26 April 2017

Strategies for pricing of pharmaceuticals and generics in developing countries

Abstract: Dr Brian Godman and Professor Mohamed Azmi Hassali review Rida et al. regarding pricing strategies for pharmaceuticals in developing countries. Submitted: 15 March 2017; Revised: 22 March 2017; Accepted:...

Author(s): Brian Godman, BSc, PhD, Professor Mohamed Azmi Hassali, PhD

developing countries, generics, pharmaceutical pricing policy

DOI: 10.5639/gabij.2017.0602.013

10.069 views

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Review Article

Published on 03 December 2021

Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

Author byline as per print journal: Esteban Ortiz-Prado1, MD, MSc, MPH, PhD(c); Enrique Teran2, MD, PhD; Raul Patricio Fernandez Naranjo1, MSc; Doménica Cevallos-Robalino1, MD; Eduardo Vasconez1, MD; Alex Lister3, MPH At...

biosimilars, black market, COVID-19 pandemic, interleukins, tocilizumab

DOI: 10.5639/gabij.2021.1004.023

9.977 views

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Meeting Report

Published on 20 March 2014

1st ASEAN overview workshop on GMP for biologicals/biosimilars 2018 – Report

Introduction: The Association of Southeast Asian Nations (ASEAN) Overview Workshop on GMP for Biologicals and Biosimilars was co-organized with the Generics and Biosimilars Initiative (GaBI). This meeting was intended to...

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Elwyn Griffiths, DSc, PhD

ASEAN, biologicals, biosimilars, GMP

DOI: 10.5639/gabij.2019.0803.015

9.955 views

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Editorial

Published on 13 March 2013

Health authority perspective on biosimilars

Abstract: Dr Brian Godman reviews Mr Gustaf Befrits’ paper on the case for biosimilars from a payer’s perspective. Biosimilars are increasingly important to payers with growing resource pressures. However, key...

Author(s): Brian Godman, BSc, PhD

biosimilars, economics

DOI: 10.5639/gabij.2013.0201.010

9.922 views

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Perspective

Published on 17 October 2017

40th anniversary of essential medicines: a loud call for improving its access

Author byline as per print journal: Mohammad Bashaar, PhD; Professor Mohamed Azmi Hassali, PhD; Fahad Saleem, PhD Abstract: The soaring costs of medicine are a global dilemma. It was hoped that the...

Author(s): Fahad Saleem, Mohammad Bashaar, Professor Mohamed Azmi Hassali, PhD

access barriers, affordability, essential medicines, medicine prices

DOI: 10.5639/gabij.2017.0604.036

9.919 views

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Original Research

Published on 30 November 2020

Biosimilars – status in July 2020 in 16 countries

Author byline as per print journal: Hye-Na Kang1, PhD; Robin Thorpe2, PhD; Ivana Knezevic1, PhD; Daehyun Baek3, PhD; Parichard Chirachanakul4; Hui Ming Chua5; Dina Dalili6, PhD; Freddie Foo7, MSc; Kai...

approval, biosimilar, survey, WHO

DOI: 10.5639/gabij.2021.1001.002

9.818 views

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Review Article

Published on 28 February 2022

Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Adelia Pheh1, BSc (Pharm) (Hon); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm)...

challenges, COVID-19 vaccines, harmonization, manufacturing, regulation, traditional vaccines

DOI: 10.5639/gabij.2022.1101.004

9.767 views

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