Articles

Letters to the Editor

Published on 02 October 2017

Clear naming, traceability of biological medicines will protect patients

Author byline as per print journal: Adjunct Professor Valderilio Feijó Azevedo, MD, PhD, MBA; Associate Professor Brian Bressler, MD, MS, FRCPC; Madelaine A Feldman, MD, FACR; Professor Alejandro Mercedes, MD Abstract:...

Author(s): Alejandro Mercedes, MD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Brian Bressler, MD, Madelaine A Feldman, MD, FACR

Biological Qualifier (BQ), biosimilars, International Nonproprietary Name (INN), naming, pharmacovigilance, World Health Organization (WHO)

DOI: 10.5639/gabij.2017.0604.031

5.477 views

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Letters to the Editor

Published on 14 December 2017

Comment on the non-biological complex drugs paper

Abstract: Comment on the Special Report by Professor Gerrit Borchard: Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias, published in GaBI Journal, 2016;5(1):36-41. Submitted: 3 November 2017; Revised: 13...

Author(s): Karthik Bodhinathan, PhD, MSM

Glatiramer acetate, multiple sclerosis, non-biological complex drugs

DOI: 10.5639/gabij.2017.0604.032

5.386 views

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Special Report

Published on 13 November 2017

Building stakeholder confidence in biosimilar medicines through evidence-based information sharing

Abstract: The European Commission held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines provided an update of the...

Author(s): Assistant Professor Gianluca Trifirò, MD, PhD

best practice, biosimilar, interchangeability, pharmacovigilance, switching

DOI: 10.5639/gabij.2017.0604.038

5.321 views

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Readers' Comments

Published on 01 August 2012

A patient-centred paradigm for the biosimilars market

A patient-centred paradigm for the biosimilars market This article provides important insights into the use and application of complex biologicals, particularly biosimilars, in health delivery systems. One aspect of care that has...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.024

5.276 views

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Review Article

Published on 07 April 2022

Long-acting insulin analogues. Drug selection by means of the System of Objectified Judgement Analysis (SOJA)

Author byline as per print journal: Robert Janknegt, PharmD, PhD; Marloes Dankers, MSc Study objectives: The increasing number of long-acting insulin analogues makes it difficult for general practitioners to have...

degludec, detemir, diabetes mellitus, glargine, long-acting insulin analogues, NPH insulin

DOI: 10.5639/gabij.2022.1101.005

5.225 views

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Published on 26 March 2015

Online biosimilars resource for patients across Latin America

Submitted: 6 March 2015; Revised: 9 March 2015; Accepted: 10 March 2015; Published online first: 23 March 2015 A new online resource on biological and biosimilar medicines in Latin America...

Author(s): Ian Ford

DOI: 10.5639/gabij.2015.0402.021

5.200 views

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Perspective

Published on 25 November 2019

An evolving role for non-governmental organizations dealing with registration backlogs and rising costs: the example of cancer biosimilars in South Africa

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...

Author(s): Paul Malherbe, PhD

biosimilars, non-governmental organizations, registration backlog, regulation

DOI: 10.5639/gabij.2020.0901.004

5.088 views

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Abstracted Scientific Content

Published on 01 February 2017

Effective generics substitution

Submitted: 19 January 2017; Revised: 20 January 2017; Accepted: 23 January 2017; Published online first: 6 February 2017 In an article published in US Pharmacist [1] Manigault et al. emphasize...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0602.019

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Abstracted Scientific Content

Published on 03 December 2018

How does generic drug policy affect market prices?

Submitted: 21 November 2018; Revised: 22 November 2018; Accepted: 28 November 2018; Published online first: 4 December 2018 A study published by the World Health Organization (WHO) compares the effect...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0703.027

5.041 views

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Editor's Letter

Published on 03 July 2013

What to look forward to in GaBI Journal, 2013, Issue 2

The first of two Letters to the Editor is from Ms Gaspani and Ms Milani expressing their concerns about the lack of clear regulatory guidelines for approval of liposomal generic...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0202.028

5.013 views

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Editorial

Published on 05 January 2023

Response to the Opinion entitled ‘Biosimilars drug development: time for a paradigm shift?’

Abstract: The Opinion published in this issue of GaBI Journal titled ‘Biosimilars drug development: time for a paradigm shift?’ by Sandeep N Athalye, Shivani Mittra and Ankitkumar M Ranpur proposes...

Author(s): Robin Thorpe, PhD, FRCPath

biosimilars, clinical trials, guidance, immunogenicity, regulatory

DOI: 10.5639/gabij.2023.1201.002

4.992 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

4.975 views

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