Articles

Thank you to reviewers

Published on 30 May 2016

Thank you to reviewers 2012

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...

2.564 views

Read more →

Review Article

Published on 04 May 2016

Assessment of the interchangeability between generics

Author byline as per print journal: Luther Gwaza1,2, BPharm, MPhil; John Gordon3, PhD; Henrike Potthast4, PhD; Marc Maliepaard5, PhD; Jan Welink5, Hubert Leufkens1,5, PhD; Matthias Stahl6, MD; Alfredo García-Arieta7, PhD...

Author(s): Alfredo García Arieta, PhD, Henrike Potthast, PhD, Hubert Leufkens, PhD, Jan Welink, John Gordon, PhD, Luther Gwaza, BPharm, MPhil, Marc Maliepaard, PhD, Matthias Stahl, MD

adjusted indirect comparisons, bioequivalence, drug switching, generic medicines, interchangeability, prequalification

DOI: 10.5639/gabij.2016.0502.015

12.434 views

Read more →

Editor's Letter

Published on 04 May 2016

Editor’s introduction to the initial issue of the fifth volume of GaBI Journal

This issue begins with a Letter to the Editor by Professor Fabio V Teixeira from the Brazilian Inflammatory Bowel Disease (IBD) Society that deals basically with the issue of extrapolation...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0501.001

3.157 views

Read more →

Perspective

Published on 27 April 2016

New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications

Author byline as per print journal: Valderílio Feijó Azevedo1,2, Alejandra Babini3,4, Fabio Vieira Teixeira5,6, Igor Age Kos1,2, Pablo Matar7 Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual...

Author(s): Alejandra Babini, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Igor Age Kos, Pablo Matar, PhD, Professor Fabio V Teixeira, MSc, MD, PhD

biosimilarity, extrapolation, infliximab, interchangeability, monoclonal antibodies, rituximab

DOI: 10.5639/gabij.2016.0502.017

12.287 views

Read more →

Commentary

Published on 18 April 2016

Waiver of consent for retrospective chart review studies

Abstract: The importance of obtaining IRB/EC consent for waiver of consent before embarking on retrospective chart review studies was highlighted using the recent case of a manuscript submitted to GaBI...

Author(s): Professor Philip D Walson, MD

chart review, consent, retrospective, waiver

DOI: 10.5639/gabij.2016.0501.004

16.054 views

Read more →

Abstracted Scientific Content

Published on 18 April 2016

The case for reforming drug naming

Submitted: 29 February 2016; Revised: 15 March 2016; Accepted: 16 March 2016; Published online first: 29 March 2016 Use of brand name drugs over generic equivalents after expiration of exclusivity...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.012

4.961 views

Read more →

Special Report

Published on 07 April 2016

Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias

Abstract: Pharmacopoeias, as standard references for pharmaceutical drug specifi cations and reference standards in the form of monographs, play a pivotal role to assure drug quality and safety. With emphasis...

Author(s): Professor Gerrit Borchard, PharmD, PhD

drug quality, ICH, non-biological complex drug (NBCD), Ph. Eur., pharmacopoeia, USP

DOI: 10.5639/gabij.2016.0501.009

18.035 views

Read more →

Commentary

Published on 07 April 2016

Low-cost generic drug programs in the US: implications for payers and researchers

Abstract: Low-cost generic drug programs (LCGPs) provide affordable generics in the US. However, LCGPs have implications for managed care organizations and researchers relying on claims data. Submitted: 7 March 2016;...

Author(s): Joshua D Brown, PharmD, MS

generic medications, low-cost generic drug programs, quality assessment, United States healthcare system

DOI: 10.5639/gabij.2016.0501.003

4.746 views

Read more →

Pharma News

Published on 15 March 2016

Top developments in biosimilars during 2015

Submitted: 14 January 2016; Revised: 26 January 2016; Accepted: 27 January 2016; Published online first: 9 February 2016 Once again the biosimilars industry has had a busy year [1]. Perhaps...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.010

7.589 views

Read more →

Legal

Published on 08 March 2016

Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update

Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by medicines regulatory bodies, such as the US Food and Drug Administration....

Author(s): Brian J Malkin, Esq, Esq

351(k), Federal Circuit, interchangeable biosimilar, Japan Pharmaceuticals and Medical Devices Agency (PMDA), patent litigation linkage, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0502.016

8.979 views

Read more →

Review Article

Published on 09 February 2016

An ever-evolving landscape: an update on the rapidly changing regulation and reimbursement of biosimilars in Canada

Author byline as per print journal: Eric CK Siu1,4, MSc, PhD; Anne Tomalin2,4, BA, BSc; Kevin West3,4, BA; Sandra Anderson4, BA, MBA; George Wyatt1,4, BSc, MBA Abstract: Since the introduction...

Author(s): Anne Tomalin, BA, BSc, Eric CK Siu, MSc, PhD, George Wyatt, BSc, MBA, Kevin West, BA, Sandra Anderson, BA, MBA

biosimilars, CADTH CDR, CADTH pCODR, Health Canada, INESSS, pCPA

DOI: 10.5639/gabij.2019.0803.014

11.717 views

Read more →