Articles

Abstracted Scientific Content

Published on 29 May 2019

Regulatory requirements for the acceptance of foreign comparator products in the participants of the International Generic Drug Regulators Programme

Submitted: 4 March 2019; Revised: 25 April 2019; Accepted: 27 April 2019; Published online first: 30 April 2019 The availability of quality generic drug products plays an increasingly important role...

Author(s): Alfredo García Arieta, PhD

DOI: 10.5639/gabij.2019.0801.005

14.916 views

Read more →

Perspective

Published on 01 August 2012

Health professionals in the risk communication process on counterfeit medicines

Abstract:  Communication is a key component in the fight against counterfeit medicines affecting the lives of patients. Two types of risk communication should be distinguished: pro-active and reactive. Reactive communication...

Author(s): Luc Besançon

counterfeit medicines, healthcare professionals, risk communication

DOI: 10.5639/gabij.2012.0103-4.026

14.859 views

Read more →

Commentary

Published on 20 January 2014

The biosimilar name debate: what’s at stake for public health

Abstract: As the number of innovator biologics and biosimilars increases worldwide, a growing debate has focused on how these products should be named. The simple concept of a name can...

Author(s): Emily A Alexander, JD

adverse event reporting, biosimilars, naming

DOI: 10.5639/gabij.2014.0301.005

14.722 views

Read more →

Opinion

Published on 01 June 2018

Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance

Abstract: Biosimilar drugs have suffered slow entrance and acceptance rates in the US market, due not only to common misperceptions among the public but also US Food and Drug Administration...

Author(s): Adjunct Professor Sarfaraz K Niazi, PhD, SI, FRSB, FPAMS, FACB

analytical similarity, biosimilars, immunogenicity testing, pharmacokinetic profiling

DOI: 10.5639/gabij.2018.0702.018

14.621 views

Read more →

Conference Report

Published on 03 July 2012

The potential of generics policies: more room for exploitation–PPRI Conference Report

Author byline as per print journal: Sabine Vogler, PhD; Nina Zimmermann, MA Introduction: This Conference Report aims to provide an overview of key results, messages and conclusions of the Pharmaceutical Pricing and Reimbursement...

Author(s): Sabine Vogler, PhD, Nina Zimmermann, MA

competition, conference, generics policies, generics uptake, medicine prices, pricing, reimbursement

DOI: 10.5639/gabij.2012.0103-4.030

14.364 views

Read more →

Regulatory

Published on 06 August 2013

US state legislation on biosimilars substitution

Abstract: Despite the fact that US Food and Drug Administration has yet to receive a biosimilars application, many US states have been considering legislation which could potentially limit biosimilars substitution....

Author(s): GaBI Journal Editor

biologicals, biosimilars substitution, state legislation

DOI: 10.5639/gabij.2013.0203.040

14.330 views

Read more →

Review Article

Published on 04 July 2016

The generic medicines system in Italy: scenarios for sustainable growth

Author byline as per print journal: Federico Fontolan1, MA; Silvia Zucconi1, MStat; Carlo Piccinni2, PhD Abstract: In this paper, an overview is provided of the present Italian generic medicines system....

Author(s): Carlo Piccinni, PhD, Federico Fontolan, MA, Silvia Zucconi, MStat

economic sustainability, generic medicines, manufacturing provision, pharmacoeconomics

DOI: 10.5639/gabij.2016.0503.029

14.246 views

Read more →

Meeting Report

Published on 18 November 2013

First Asia-Pacific educational workshop on non-biological complex drugs (NBCDs), Kuala Lumpur, Malaysia, 8 October 2013

Author byline as per print journal: Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD, Beat Flühmann, PhD Introduction: In recent years a new category of medicinal products, the non-biological...

Author(s): Beat Flühmann, PhD, Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD

follow-on drugs, nanomedicines, NBCD, non-biologic complex drugs, regulatory practice

DOI: 10.5639/gabij.2014.0301.010

14.162 views

Read more →

Abstracted Scientific Content

Published on 29 November 2012

Alleviating concerns around generic antiepileptic medications

Epilepsy features the unpredictable onset of seizures that can be devastating to a patient’s quality of life. Fortunately there are medications available to control the onset of seizures. But because...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0201.002

14.150 views

Read more →

Review Article

Published on 30 March 2022

Manufacture and regulation of cell, tissue and gene therapy products: global perspectives, challenges and next steps

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Christine Koh, BSc (Pharm) (Hon); Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD Abstract: Cell,...

cell, good manufacturing practice, quality control, regulatory framework, tissue and gene therapy products

DOI: 10.5639/gabij.2022.1102.012

14.147 views

Read more →

Regulatory

Published on 20 March 2015

Korean regulations for biosimilars

Abstract: Regulations for biosimilars in the Republic of Korea have been in place since 2009. Since then, the country has also put in place specific guidelines and approved four biosimilars....

Author(s): Jeewon Joung, PhD

biosimilar, guidelines, regulation, Republic of Korea

DOI: 10.5639/gabij.2015.0402.019

13.753 views

Read more →