Articles

Regulatory

Published on 06 February 2015

Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

Abstract: Biologicals have offered a new avenue for targeting therapy to treat life-threatening and chronic diseases. The recent or pending patent expirations of many successful biologicals have permitted the marketing...

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Ally Pen, PhD

biologicals, biosimilars, clinical trials, extrapolation, immunogenicity, regulatory

DOI: 10.5639/gabij.2015.0401.009

13.009 views

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Letters to the Editor

Published on 11 December 2012

Austria increases dialogue in order to involve physicians more with biosimilars

Abstract: Comment on the GaBI Journal article titled The potential for doctors to contribute to biosimilar guidelines [1] and the GaBI Online article titled Dialogue needed to build confidence in...

Author(s): Christoph Baumgärtel, MD, MSc

DOI: 10.5639/gabij.2013.0201.003

12.972 views

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Original Research

Published on 10 July 2018

Implementing a treatment registry for a biosimilar: continuous safety surveillance of the biosimilar Bevax® (bevacizumab) in Argentina

Introduction and study objectives: Benefit-risk evaluations are essential throughout the life cycle of a drug to guarantee therapeutic efficacy for the authorized indications without an unacceptable incidence of adverse effects....

Author(s): Francisco Fernández, MD, Matías Deprati, MD, Patricia Rodríguez Acedo, Eduardo Spitzer, BSc, Alvaro Romera, MD, Nadia Español, BSc

adverse drug reaction, bevacizumab, biosimilar, monoclonal antibodies, pharmacovigilance, safety profile

DOI: 10.5639/gabij.2018.0703.023

12.947 views

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Meeting Report

Published on 13 November 2017

Perspectives on the future of pegfilgrastim biosimilars

Author byline as per print journal: Professor Pere Gascón, MD; Ruediger Jankowsky, PhD; Karsten Roth, PhD Abstract: Cinfa Biotech, the biosimilars specialists of the Cinfa Group, reviewed pegfilgrastim biosimilar approaches to...

Author(s): Karsten Roth, PhD, Professor Pere Gascón, MD, Ruediger Jankowsky, PhD

biosimilars, biotech, G-CSF, neutropenia, pegfilgrastim

DOI: 10.5639/gabij.2017.0604.040

12.908 views

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Special Report

Published on 08 May 2017

Interchangeability of biosimilars in the US and around the world

Abstract: In this paper, differences across the world are highlighted when it comes to the interchangeability of biosimilars. The lack of harmonization makes it difficult for biosimilars makers and could...

Author(s): GaBI Journal Editor

biosimilar, interchangeability

DOI: 10.5639/gabij.2017.0602.017

12.867 views

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Original Research

Published on 10 December 2015

Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico

Author byline as per print journal: Michael S Reilly, Esq; Harry L Gewanter, MD, FAAP, FACR Introduction: World Health Organization (WHO) recommendations for the regulation of biosimilars form the basis of...

Author(s): Harry L Gewanter, MD, FAAP, FACR, Michael S Reilly, Esq

Biological Qualifier (BQ), biosimilar, Latin America, naming, prescribing, World Health Organization (WHO)

DOI: 10.5639/gabij.2015.0404.036

12.689 views

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Commentary

Published on 12 June 2013

Ongoing initiatives in the Republic of Srpska to enhance prescribing efficiency; influence and future directions

Abstract: Dr Brian Godman reviews the paper by Markovic-Pekovic et al. regarding recent reforms in the Republic of Srpska. These include prescribing restrictions where concerns with the value of products...

Author(s): Brian Godman, BSc, PhD

demand-side measures, generics, renin-angiotensin inhibitor drugs, Srpska, statins, supply-side measures

DOI: 10.5639/gabij.2013.0203.029

12.635 views

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Special Report

Published on 14 December 2017

USA and Europe differ in interchangeability of biosimilars

Abstract: This paper highlights differences between USA and Europe when it comes to the interchangeability of biosimilars. The lack of harmonization between USA and Europe may introduce confusion for stakeholders...

Author(s): GaBI Journal Editor

biosimilar, EMA, interchangeability

DOI: 10.5639/gabij.2017.0604.039

12.632 views

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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

12.493 views

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Commentary

Published on 17 January 2018

EU Member States have tools to reduce costs of bestseller biologicals but can they use them?

Abstract: Major cost savings are achievable in pharmacotherapy in the European Union since biosimilars to most best-selling biological medicinal products have been licensed. Unfortunately, the window of opportunity may be...

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

automatic substitution, biosimilars, cost savings, interchangeability, payers, prescribers

DOI: 10.5639/gabij.2018.0701.002

12.486 views

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