Articles

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

6.840 views

Read more →

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

157.087 views

Read more →

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

3.551 views

Read more →

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

5.580 views

Read more →

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

8.850 views

Read more →

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

7.052 views

Read more →

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

15.240 views

Read more →

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

9.356 views

Read more →

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

18.995 views

Read more →

Original Research

Published on 17 April 2015

Product naming, pricing, and market uptake of biosimilars

Abstract: With a number of patents on biological medicines soon to expire in the US, multiple stakeholders – from policymakers to manufacturers to payers – have been debating the structure...

Author(s): Jacqueline Vanderpuye-Orgle, MSc, PhD, Joseph P Fuhr, PhD, Amitabh Chandra, PhD, John Romley, PhD, Tiffany Shih, PhD, Suepattra G May, MPH, PhD

biosimilar, market uptake, nomenclature, regulatory, specialty pharmaceuticals

DOI: 10.5639/gabij.2015.0402.015

22.252 views

Read more →