Articles

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

21.946 views

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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

3.353 views

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Meeting Report

Published on 16 September 2015

European biosimilars conference highlights extrapolation as key issue

Abstract: This paper discusses topics covered by the EGA’s April 2015 biosimilars conference, where extrapolation of indications was highlighted as a key issue. Submitted: 2 July 2015; Revised: 15 July...

Author(s): GaBI Journal Editor

biosimilar, extrapolation, similarity

DOI: 10.5639/gabij.2015.0403.032

8.251 views

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Meeting Report

Published on 25 March 2015

First Latin American educational workshop on similar biotherapeutic products, Mexico City, Mexico, 20 January 2015

Introduction: Similar Biotherapeutic Products (SBPs or biosimilars) comprise a rapidly expanding area of therapeutics worldwide. However, best practices for their regulation are lacking in many Latin American countries. Methods: The...

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

biologicals, biosimilars, follow-on drugs, Latin America, Mexico, regulatory practice

DOI: 10.5639/gabij.2015.0403.031

6.259 views

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Regulatory

Published on 11 September 2015

Regulatory requirements for the development and registration of biosimilars in South Africa

Abstract: In South Africa, medicines are registered and regulated in terms of the Medicines and Related Substances Control Act (Act 101 of 1965), as amended, and the regulations to this...

Author(s): Khamusi Philip Mutoti, BSc, BPharm Sci, Professor Nontombe Mbelle, MChB, MMed, FC Path (CMSA), Henry MJ Leng, PhD

biosimilars, comparative studies, registration requirements

DOI: 10.5639/gabij.2015.0403.033

15.905 views

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Perspective

Published on 02 June 2015

Substantial savings with generics in Austria – and still room for more

Abstract: Austria has seen considerable savings with generics, due to its unique pricing system. Generic medicine penetration is, however, not as advanced as in other European countries. Additional savings could...

Author(s): Christoph Baumgärtel, MD, MSc

Austria, generics, price

DOI: 10.5639/gabij.2015.0403.030

7.017 views

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Review Article

Published on 16 June 2015

Biosimilars patent litigation in the EU and the US: a comparative strategic overview

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

Author(s): Brian J Malkin, Esq

biosimilars, follow-on biological, Inter Partes Review, litigation, opposition, patent

DOI: 10.5639/gabij.2015.0403.026

156.902 views

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Review Article

Published on 13 April 2015

Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future

Author byline as per print journal: Brian Godman, BSc, PhD; Michael Wilcock, MPharm; Andrew Martin, MPharm; Scott Bryson, MSc, MPH; Christoph Baumgärtel, MD; Tomasz Bochenek, MD, MPH, PhD; Winne de Bruyn, BSc;...

Author(s): Brian Godman, BSc, PhD, et al.

generics, health authorities, Lyrica, pregabalin

DOI: 10.5639/gabij.2015.0403.028

24.225 views

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Letters to the Editor

Published on 15 June 2015

Access to safe and effective biopharmaceuticals

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract: Comment on the Letter to the Editor by Professor Abdol Majid Cheraghali: Access to alternative biopharmaceuticals in...

Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2015.0403.024

5.539 views

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Commentary

Published on 02 June 2015

The challenges of nomenclature – INN, biosimilars and biological qualifiers

Abstract: A novel global and company specific biological qualifier, distinct from the International Nonproprietary Name (INN), is proposed by World Health Organization (WHO) for all biological active substances. Submitted: 14...

Author(s): James S Robertson, PhD

biological active substances, Biological Qualifier (BQ), biosimilars, international non-proprietary names

DOI: 10.5639/gabij.2015.0403.025

15.056 views

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