Articles

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

6.953 views

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Abstracted Scientific Content

Published on 21 September 2015

Measuring performance in off-patent drug markets

Submitted: 10 July 2015; Revised: 13 August 2015; Accepted: 13 August 2015; Published online first: 26 August 2015 Generic medicines can play a role in curbing rising pharmaceutical costs, and...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0404.042

7.462 views

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Perspective

Published on 23 September 2015

Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Stefan Mühlebach, PhD; Vinod P Shah, PhD; Scott E McNeil, PhD; Professor Gerrit Borchard, PharmD, PhD; Vera Weinstein, PhD; Beat Flühmann,...

Author(s): Beat Flühmann, PhD, Daan JA Crommelin, Jon SB de Vlieger, PhD, Professor Gerrit Borchard, PharmD, PhD, Professor Stefan Mühlebach, PhD, Scott E McNeil, Sesha Neervannan, PhD, Vera Weinstein, PhD, Vinod P Shah, PhD

glatiramoids, iron-carbohydrate complexes, liposomes, nanomedicines, non-biological complex drug (NBCD), therapeutic equivalence

DOI: 10.5639/gabij.2015.0404.037

18.438 views

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Opinion

Published on 16 June 2015

Challenges of developing generics substitution policies in low- and middle-income countries (LMICs)

Abstract: There are few challenges to developing effective generics substitution policies in low- and middle-income countries (LMICs). These include the absence of generics substitution policies, lack of enforcement, lack of...

Author(s): Professor Mohamed Azmi Hassali, PhD, Zhi Yen Wong, BPharm (Hons), MSc (Pharmaceutical Policy), RPh

generic medicines, generics substitution, low- and middle-income countries (LMICs)

DOI: 10.5639/gabij.2015.0404.038

6.841 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

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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

22.196 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

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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

8.318 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

6.279 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

16.106 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, prices

DOI: 10.5639/gabij.2015.0403.030

7.054 views

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