Articles

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, 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

6.877 views

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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

14.942 views

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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

4.608 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) products, therapeutic equivalence

DOI: 10.5639/gabij.2015.0404.037

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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

7.417 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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Editor's Letter

Published on 16 September 2015

Latest features in GaBI Journal, 2015, Issue 3

This issue of the journal contains a number of manuscripts that discuss proposals to simplify the evaluation of, and therefore decrease the cost of developing, follow-on biological products. These controversial...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0403.022

3.643 views

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Special Report

Published on 15 September 2015

Improving biosimilars uptake: experience gained in Madrid, Spain

Abstract: How to improve the uptake of biosimilars is a question that many countries are finding a challenge. Researchers from the Madrid Health Service investigate how initiatives in Spain have...

Author(s): GaBI Journal Editor

biological, biosimilar, Spain, uptake

DOI: 10.5639/gabij.2016.0502.021

7.173 views

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