Articles

Abstracted Scientific Content

Published on 12 December 2013

Biosimilarity of anticancer monoclonal antibodies in the clinic

The European Medicines Agency recommends the use of pharmacodynamics (PD) markers when establishing biosimilarity, but no such biomarkers are known for the clinical efficacy of bevacizumab (Avastin). For this reason,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0301.013

6.557 views

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Perspective

Published on 06 August 2013

Assuring patient-centred care: engaging patients with rheumatoid arthritis in disease monitoring and pharmacovigilance

Abstract: With the advent of complex therapies in the form of biologicals, emerging biosimilars and non-biological complex drugs, monitoring for treatment related benefit and the potential for adverse effects is...

Author(s): Janet S Wyatt, RN, PhD, FAANP

biological therapy, patient engagement, pharmacovigilance, treatment response

DOI: 10.5639/gabij.2014.0301.008

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Original Research

Published on 16 December 2013

Alternative statistical strategies for biosimilar drug development

Introduction: Many regulatory authorities have published requirements for the approval of biosimilar medicinal products. However, there is no guidance on which quantitative standards should be used to define how similar...

Author(s): Austin J Combest, PharmD, MBA, Song Wang, PhD, Brian T Healey, PharmD, MS, MBA, RAC, Dirk J Reitsma, MD

Bayesian design, biosimilar, drug development, repeated measures analysis, statistics strategy

DOI: 10.5639/gabij.2014.0301.006

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Pharma News

Published on 24 January 2014

Top developments in biosimilars during 2013

The past year has been a busy one for the biosimilars industry. Perhaps one of the most important milestones during 2013 was the European approval of the first monoclonal antibody...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0301.014

8.072 views

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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

14.733 views

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Letters to the Editor

Published on 18 March 2014

Common or distinct INN for biosimilars? Only characteristics of the active substance prior to formulation should be considered

Submitted: 24 January 2014; Revised: 29 January 2014; Accepted: 30 January 2014; Published online first: 12 February 2014 To the Editor: I read with interest the letter of Dr Edward...

Author(s): Professor Paul J Declerck, PhD

DOI: 10.5639/gabij.2014.0301.003

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Editor's Letter

Published on 18 March 2014

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

This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0301.001

4.191 views

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