Articles

Published on 05 January 2016

2015/3 GaBI Journal Table of Contents

Contents Editor’s Letter Latest features in GaBI Journal, 2015, Issue 3 Editorial Advances in analytical characterization of biosimilars Letters to the Editor Access to safe and effective biopharmaceuticals Commentary The...

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Abstracted Scientific Content

Published on 16 December 2015

Promoting a competitive generics market in the US

Submitted: 15 December 2015; Revised: 15 December 2015; Accepted: 15 December 2015; Published online first: 16 December 2015 As a result of recent price increases and shortages, the US generics...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.011

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Readers' Comments

Published on 14 December 2015

Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines Comment by Ernest Schay, Bayer Thank you for this very interesting...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0404.044

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Editor's Letter

Published on 11 December 2015

Fourth and final issue of GaBI Journal’s fourth volume

This last issue of 2015 starts with a Commentary by Drs Christoph Baumgärtel and Brian Godman concerning the approval of generic versions of narrow therapeutic margin products; including immunosuppressant drugs....

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0404.034

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Special Report

Published on 11 December 2015

Supporting biosimilarity and extrapolation

Abstract: With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies...

Author(s): GaBI Journal Editor

analytics, biosimilarity, clinical studies, extrapolation

DOI: 10.5639/gabij.2015.0404.041

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Special Report

Published on 11 December 2015

Patent expiry dates for best-selling biologicals

Abstract: Biosimilars have been approved in Europe since 2006. With patents on originator biologicals expiring and ever-tightening healthcare budgets biosimilars are likely to take an increasing share of the biologicals...

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2015.0404.040

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Meeting Report

Published on 11 December 2015

First MENA educational workshop on regulation and approval of similar biotherapeutic products/biosimilars, Dubai, United Arab Emirates, 1 September 2015

Introduction: Similar biotherapeutic products (SBPs or biosimilars) include a rapidly expanding number of therapeutic products worldwide. However, agreement about the best practices for their regulation are lacking in many countries...

Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, follow-on drugs, MENA (Middle East and North Africa), regulatory practice

DOI: 10.5639/gabij.2015.0404.039

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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

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Abstracted Scientific Content

Published on 07 December 2015

Immunogenicity assessment of monoclonal antibodies

Submitted: 6 October 2015; Revised: 10 October 2015; Accepted: 12 October 2015; Published online first: 26 October 2015 The most critical safety concern relating to biologicals (including biosimilars) is immunogenicity....

Author(s): GaBI Online Editor

DOI: 10.5639/gabij.2015.0404.043

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Review Article

Published on 20 November 2015

Life begins at forty – hybridomas: ageing technology holds promise for future drug discoveries

Abstract: Hybridomas were developed in 1975 as a stable platform for creating monoclonal antibodies (mAbs). Over the past 40 years, hybridomas have been a leading platform for creating mAbs, yet...

Author(s): Tim Steele, BS

hybridomas, microfluidics, monoclonal antibodies

DOI: 10.5639/gabij.2016.0501.006

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Commentary

Published on 19 November 2015

Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Author byline as per print journal: Christoph Baumgärtel, MD, MSc; Brian Godman, BSc, PhD Abstract: Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as...

Author(s): Brian Godman, BSc, PhD, Christoph Baumgärtel, MD, MSc

bioequivalence, ciclosporin, EMA, generics, immunosuoppressives, narrow therapeutic index drugs

DOI: 10.5639/gabij.2015.0404.035

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Abstracted Scientific Content

Published on 23 September 2015

Escalating prices of generic drugs targeted by US anti-gouging legislation

Submitted: 29 January 2019; Revised: 4 February 2019; Accepted: 5 February 2019; Published online first: 14 February 2019 Generic prescription drug prices have been escalating rapidly in the US. In...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2019.0802.010

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