Articles

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

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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

7.458 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

8.313 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

3.671 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

7.210 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

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Published on 19 June 2015

2015/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2015, Issue 2 Commentary Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines Original...

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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

6.835 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

157.077 views

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Editor's Letter

Published on 15 June 2015

What to look forward to in GaBI Journal, 2015, Issue 2

This entire issue of the GaBI Journal could be titled ‘World News’ since it contains manuscripts describing global generics and biosimilar activities. The Commentary by Leng et al. describes regulatory...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0402.013

3.550 views

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