The International Alliance of Patients’ Organizations (IAPO) is an alliance of over 200 patient groups that represents the interests of patients worldwide. In November 2013, IAPO published its Information and Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations [1]. The Toolkit was developed to provide up-to-date, evidence-based information on the science, technology, and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.045

Abstract: Alternative biopharmaceuticals could substantially improve affordability of biotherapeutics in developing countries. However, it seems that these countries need a modified regulatory pathway to guarantee timely access to these medicines. Submitted: 27 August 2014; Revised: 14 September 2014; Accepted: 15 September 2014; Published online first: 29 September 2013 In recent years, biotherapeutics have gained a…

Author(s): Professor Abdol Majid Cheraghali, PharmaD, PhD

affordability, alternative biopharmaceuticals, regulation

DOI: 10.5639/gabij.2014.0304.038

Abstract: The attractiveness of the biosimilar regulatory pathway is threatened by so-called biobetters. This paper provides definitions and an overview of recent developments. Submitted: 27 October 2014; Revised: 7 November 2014; Accepted: 12 November 2014; Published online first: 25 November 2014 Concerning the biosimilar landscape, the European Medicines Agency (EMA) was among the first institutions…

Author(s): René Anour, DVM

biobetter, biosimilar, competition, interchangeability, regulatory pathways

DOI: 10.5639/gabij.2014.0304.039

Abstract: Dr Brian Godman reviews the paper by Vogler and co-authors on the procurement of generics or originators among European hospitals once multiple sources become available. Submitted: 28 November 2014; Revised: 3 December 2014; Accepted: 3 December 2014; Published online first: 16 December 2014 Vogler and co-authors have provided valuable insight into the procurement of…

Author(s): Brian Godman, BSc, PhD

Europe, generics, hospitals, procurement

DOI: 10.5639/gabij.2014.0304.037

Editor's Letter

Published on 17 December 2014

Fourth and final issue of GaBI Journal’s third volume

The interest in the development, regulatory approval, use, and post-marketing surveillance of generic and biosimilar pharmaceutical products continues to increase; as illustrated by the tremendous number of views (over 1,028,324 since 2012) of articles published in the GaBI Journal. I expect that this interest will continue to increase after publication of this fourth and final…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0304.036

Abstract: Representatives from Amgen and Actavis have spoken to GaBI (Generics and Biosimilars Initiative) about biosimilars. Topics covered included the clinical development of biosimilars, the need for further education, how the partnership model between the companies was working, the commercialization of biosimilars and their views on non-proprietary names for biosimilars Biotech giant Amgen and generics…

Author(s): GaBI Journal Editor

biosimilar, clinical development, commercializaiton, INN

DOI: 10.5639/gabij.2014.0303.035

Abstract: The principles Health Canada use when extrapolating the indications and uses of a biosimilar product subsequent to a single clinical trial or limited number and scope of clinical trials during product development are discussed. The principles underlying the regulatory framework for subsequent entry biologics (SEBs or biosimilars) in Canada explain the position taken by…

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Patrick Bedford, BSc, MA

biosimilar, Canada, reference biological product, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2014.0303.033

Author byline as per print journal: Valderilio Feijó Azevedo, MD, PhD; Eduardo Mysler, MD; Alexis Aceituno Álvarez, PharmD, PhD; Juana Hughes, MSc; Francisco Javier Flores-Murrieta, PhD, FCP; Eva Maria Ruiz de Castilla, MS, MAA, PhD Abstract: With the emergence of biosimilars as a new class of biotherapeutic agents, the use of these products in Latin America has become a focus…

Author(s): Alexis Aceituno Álvarez, PharmD, PhD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Eduardo Mysler, MD, Eva Maria Ruiz de Castilla, MS, MAA, PhD, Francisco Javier Flores-Murrieta, PhD, FCP, Juana Hughes, MSc

biological products, biosimilarity, biosimilars, Latin America, reference biotherapeutic product (RBP), regulatory pathways

DOI: 10.5639/gabij.2014.0303.032

Author byline as per print journal: Wenjie Zeng, BSc, PhD; Houmei Xi, B Eng; Brian Godman, BSc, PhD; Alexander E Finlayson, MD, MRCP;  Rickard E Malmstrom, MD, PhD Introduction: Pharmaceutical expenditure rose by 16% per annum in China during the past decade, and now represents 46% of total healthcare expenditure. Initiatives to moderate growth include pricing…

Author(s): Alexander E Finlayson, MD, MRCP, Brian Godman, BSc, PhD, Houmei Xi, B Eng, Rickard E Malmstrom, MD, PhD, Wenjie Zeng, BSc, PhD

China, drug utilization study, generics, health policies, pharmaceuticals, statins

DOI: 10.5639/gabij.2014.0303.030

Author byline as per print journal: Joshua P Cohen, PhD; Abigail E Felix, BA; Kim Riggs, MPH; Anumeha Gupta, MD Background: In the US, a new approval pathway for biosimilars has been established as part of the Affordable Care Act. Biosimilars are anticipated to increase treatment options and lower the growth in spending on biologicals. How the commercial…

Author(s): Abigail E Felix, BA, Anumeha Gupta, MD, Joshua P Cohen, PhD, Kim Riggs, MPH

biosimilar, formulary, interchangeability, originator biological, payers, price discount, therapeutic switching

DOI: 10.5639/gabij.2014.0303.028

Author byline as per print journal: Robert Janknegt, PharmD, PhD, Niels Boone, PharmD, Frans Erdkamp, MD, PhD, Victor Zambon, MD Abstract: This manuscript describes the System of Objectified Judgement Analysis (SOJA) method applied to gonadotropin-releasing hormone (GnRH) agonists and antagonists in prostate cancer. The following selection criteria were used: efficacy, safety, tolerability, dosage frequency, user-friendly…

Author(s): Frans Erdkamp, MD, PhD, Niels Boone, PharmD, Robert Janknegt, PharmD, PhD, Victor Zambon, MD

drug selection, GnRH (gonadotropin-releasing hormone) agonists, GnRH antagonists, goserelin, leuprorelin, prostate cancer, SOJA (System of Objectified Judgement Analysis) method

DOI: 10.5639/gabij.2014.0303.031

Author byline as per print journal: Professor Jacques Rottembourg, MD; Corinne Emery, MSc; Alessandra Moglia, PhD Study objective: To describe and compare the haematological parameters and the anaemia medication use in haemodialysis patients who were switched from the originator iron sucrose (IS) to an iron sucrose similar (ISS). Methods: A retrospective observational single-centre study describing chronic…

Author(s): Alessandra Moglia, PhD, Corinne Emery, MSc, Jacques Rottembourg, MD

anaemia, cost, haemodialysis, interchangeability, iron sucrose, iron sucrose similar, non-biological complex drug (NBCD), oxidative stress

DOI: 10.5639/gabij.2014.0303.029