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 events in South Africa that led to claims of delay in marketing approval of generic drug products. The authors discuss the relationship between regulatory policies…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0402.013

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 low- and middle-income countries, published in GaBI Journal, 2014;4(3):164-5. Submitted: 7 June 2015; Revised: 8 June 2015; Accepted: 8 June 2015; Published online first: 22…

Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2015.0403.024

Abstract: Biosimilars should be approved for all the clinical indications of the reference product based on the totality of the evidence even if there is no clinical safety and efficacy data for each indication. The foundation of biosimilar development is the demonstration that chemical, physical and biological parameters are highly similar to the reference product.…

Author(s): David R Gaugh, RPh, Theresa L Gerrard, PhD, Gordon Johnston, RPh, MS

biosimilar, clinical indication, comparability, extrapolation

DOI: 10.5639/gabij.2015.0403.027

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 Wernecke2, BA; Thomas MaCurdy2,4, PhD; Jeffrey A Kelman5, MD, MMSc Background: Drug pricing and availability are key concerns for reducing healthcare costs and meeting patient…

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

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 be made, provided certain measures are implemented. Submitted: 27 May 2015; Revised: 5 June 2015; Accepted: 8 June 2015; Published online first: 22 June 2015…

Author(s): Christoph Baumgärtel, MD, MSc

Austria, generics, prices

DOI: 10.5639/gabij.2015.0403.030

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 May 2015; Revised: 2 July 2015; Accepted: 6 July 2015; Published online first: 20 July 2015 Introduction to INN The concept of one single non-proprietary…

Author(s): James S Robertson, PhD

biological active substances, Biological Qualifier (BQ), biosimilars, international non-proprietary names

DOI: 10.5639/gabij.2015.0403.025

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 of the current situation. Submitted: 21 April 2015; Revised: 8 May 2015; Accepted: 11 May 2015; Published online first: 25 May 2015 The Biologics Price…

Author(s): GaBI Journal Editor

biologicals, biosimilars, legislation, notification, substitution

DOI: 10.5639/gabij.2015.0402.020

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: 18 May 2015; Revised: 22 May 2015; Accepted: 26 May 2015; Published online first: 8 June 2015 Introduction Drug budgets and total healthcare expenditure can…

Author(s): Asbjørn Mack, MD

biosimilars, discounts, market penetration, tender

DOI: 10.5639/gabij.2015.0402.018

Abstract: The first recognized and trusted generic drugs were launched in France in 1995, at the same time that the Prime Minister Alain Juppé introduced his new plan on Retirement and Social Security. It has taken 20 years for generic drugs to become integrated into the pharmacy community, and for acceptance to be reached by…

Author(s): Jacques Rottembourg, MD, Jessica Nasica-Labouze, PhD

biosimilars, generic drug repertory, generics, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2015.0403.029

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 of regulatory frameworks and in particular, naming conventions for biosimilars. A key area of concern has been the potential impact of naming, and specifically, whether…

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

Contents Editor’s Letter Editor’s introduction to the initial issue of the fourth volume of GaBI Journal Editorial Biosimilars: patient and physician acceptability is the fifth hurdle to market competition Letters to the Editor Generic medicines policy in Qatar Commentary The EU regulatory approach to generics and biosimilars is essentially similar Original Research Payer and physician…

Author byline as per print journal: Brian Godman, BSc, PhD; Michael Wilcock, MPharm; Andrew Martin, MPharm; Scott Bryson, MSc, MPH; Christoph Baumgärtel, MD; Tomasz Bochenek, MD, MPH, PhD; Winne de Bruyn, BSc; Ljiljana Sović Brkičić, MPharm; Marco D’Agata, MSc; Antra Fogele, PhD; Anna Coma Fusté, MSc; Jessica Fraeyman, PhD; Jurij Fürst, MD; Kristina Garuoliene, MD, PhD; Harald Herholz, MD,…

Author(s): Brian Godman, BSc, PhD, et al.

generics, health authorities, Lyrica, pregabalin

DOI: 10.5639/gabij.2015.0403.028