Articles

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

15.904 views

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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...

3.175 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

6.763 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

156.901 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

3.539 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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Original Research

Published on 03 June 2015

Pharmacy chain drives choice among manufacturers of generic drugs in the US Medicare population

Author byline as per print journal: Steven Kozlowski1, MD; Ellen Tworkoski2, MS, MPhil; Carmen Dekmezian2, MS; Yanchang Zhang2, MPH; Natasha Flowers2, BA; Alvin So3, MS; Andreas M Schick3, PhD; Michael...

Author(s): Jeffrey A Kelman, MD, MMSc, Steven Kozlowski, MD, Ellen Tworkoski, MS, MPhil, Carmen Dekmezian, MS, Yanchang Zhang, MPH, Natasha Flowers, BA, Alvin So, MS, Andreas M Schick, PhD, Michael Wernecke, BA, Thomas MaCurdy, PhD

generic drugs, pharmacy, US Medicare

DOI: 10.5639/gabij.2019.0803.013

8.739 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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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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Regulatory

Published on 28 May 2015

Update on US state legislation on biosimilars substitution

Abstract: Since the biosimilars pathway was introduced, many US states have been considering, or have introduced, legislation to allow for substitution of biosimilars deemed interchangeable. This paper gives an update...

Author(s): GaBI Journal Editor

biologicals, biosimilars, legislation, notification, substitution

DOI: 10.5639/gabij.2015.0402.020

9.294 views

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Perspective

Published on 28 May 2015

Norway, biosimilars in different funding systems. What works?

Abstract: Biosimilars can substitute treatment with expensive biological drugs and release money to treat more patients. Experience from Norway shows how this can be done with and without success. Submitted:...

Author(s): Asbjørn Mack, MD

biosimilars, discounts, market penetration, tender

DOI: 10.5639/gabij.2015.0402.018

18.789 views

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