Articles

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

17.191 views

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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

6.558 views

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Editor's Letter

Published on 05 December 2013

GaBI Journal publishes four issues in 2013

This issue marks the forth and final issue of the second year’s edition of the GaBI Journal. The journal has grown rapidly through the combined efforts of the publisher and...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0204.042

11.609 views

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Abstracted Scientific Content

Published on 04 December 2013

Biosimilar monoclonal antibodies – time for a regulatory rethink

The approval of biosimilars in the European Union (EU) is governed by the EU biosimilar framework released in 2004. But new arrivals on the biosimilar stage – monoclonal antibodies –...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0203.041

8.944 views

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Editorial

Published on 04 December 2013

Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise?

Abstract: Despite the fact that hepatitis C is a disease of global importance, many countries cannot afford the costly but effective combination treatment of peg-interferon and ribavirin, which was recently...

Author(s): Armando A Genazzani, DPhil, MD, Nicola Magrini, MD

alternative therapeutic products, biosimilar, essential medicines, peginterferon, regulatory approval pathways, World Health Organization (WHO)

DOI: 10.5639/gabij.2013.0204.044

20.826 views

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Letters to the Editor

Published on 27 November 2013

Critical immunogenicity differences will be obscured by a common INN for biosimilars

Abstract: Information about variable immunogenicity arising from formulation differences between competing biosimilars is critical for informed judgments by prescribing physicians. Use of a common INN for biosimilars will obfuscate such...

Author(s): Edward T Maggio, PhD

immunogenicity, INN, neoantigen, neutralizing antibodies, oxidative damage, polysorbate, protein aggregation

DOI: 10.5639/gabij.2013.0204.046

6.338 views

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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, non-biological complex drug (NBCD), regulatory practice

DOI: 10.5639/gabij.2014.0301.010

14.186 views

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Special Report

Published on 18 November 2013

Analysis of European policy towards generic medicines

Abstract: In this paper, we provide an overview of a PhD project we undertook on European policy on generic medicines. In the course of our research, we identified various causes...

Author(s): Pieter Dylst, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP, Steven Simoens, MSc, PhD

demand-side policies, Europe, European policy, generic medicines, supply-side policies

DOI: 10.5639/gabij.2014.0301.011

16.453 views

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Perspective

Published on 18 November 2013

Role of hospital clinical pharmacist in transplantation, and generic immunosuppressive therapies

Abstract: The pharmacist is an important patient advocate in the transplant multidisciplinary team and can support patients in their medication taking to improve medication adherence. Medicine optimization and patient information...

Author(s): Andrea Devaney

generics substitution, immunosuoppressives, self-medication, tacrolimus, transplantation

DOI: 10.5639/gabij.2014.0302.023

26.121 views

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Letters to the Editor

Published on 12 November 2013

Biosimilars naming and prescribing policy in Australia

Submitted: 31 October 2013; Revised: 6 November 2013; Accepted: 11 November 2013; Published online first: 25 November 2013 To the Editor: I wanted to bring to your attention the following...

Author(s): Brendan Shaw, PhD

DOI: 10.5639/gabij.2013.0204.048

8.951 views

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Letters to the Editor

Published on 29 October 2013

Legislative efforts to limit prescription information sharing between patients and healthcare providers represent a serious threat to the health and safety of the American nation

Abstract: Legislation in support of pharmacist notification to patients and providers of substitution of an interchangeable biologic for the originator biologic was recently vetoed in California. Automatic substitution of approved...

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

biologicals, patients, REMS

DOI: 10.5639/gabij.2013.0204.045

6.571 views

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