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, 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

Results of a survey carried out by the European Crohn’s and Colitis Organisation (ECCO) highlight a lack of confidence in biosimilars and the need for continued education. The results of the ECCO 2013 survey [1] were presented by Dr Alessandro Armuzzi, together with the EU physician 2013 survey on naming, transparency and traceability for biosimilars…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0303.034

Abstract: The situation in many countries regarding the procedure used to evaluate ‘biosimilars’ is not always clear. In this issue of GaBI Journal, Azevedo et al. review the regulatory situation for biosimilars in Latin America. It is intended to publish reviews covering the regulatory situation with biosimilars in other countries/geographical areas in future issues of…

Author(s): Robin Thorpe, PhD, FRCPath

biosimilars, follow-on products, Latin America, regulatory processes

DOI: 10.5639/gabij.2014.0303.027

Editor's Letter

Published on 05 September 2014

Latest features in GaBI Journal, 2014, Issue 3

This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their implementation in some Latin American countries. Three Original Research papers describe real life clinical examples relating to the use and evaluation of follow-on products respectively;…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0303.026

It is far from clear whether off-patent biological medicines can offer the same cost savings as those offered by off-patent non-biological (chemically derived) medicines, write a group of Brussels-based health economists in the European Journal of Health Economics. Several key factors will play a role in realizing the potential of these effective low-cost agents, including…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0302.025

Abstract: The pharmacist is an important patient advocate in the transplant multidisciplinary team and can support patients in their medication taking to improve medication adherence. Medicine optimization and patient information are also vital to this aim. For more than 20 years patients transplanted at our institution have undergone a structured post-operative self-medication training programme so…

Author(s): Andrea Devaney

generics substitution, immunosuoppressives, self-medication, tacrolimus, transplantation

DOI: 10.5639/gabij.2014.0302.023

Abstract: The arrival of biosimilars has led to considerable debate on how they can be used in clinical practice. A particular concern is related to the question of whether a biosimilar can be safely interchanged with the originator product or other biosimilars. Here we will discuss challenges to the regulatory approach for establishing interchangeability, in…

Author(s): Hans C Ebbers, PhD, Paul Chamberlain, BSc

biosimilars, immunogenicity, interchangeability, monoclonal antibodies, substitution, switching

DOI: 10.5639/gabij.2014.0302.022

Author byline as per print journal: Niels Eckstein, PhD; Lea Röper, BSc; Bodo Haas, PhD; Henrike Potthast, PhD; Ulrike Hermes, PhD; Christoph Unkrig, MD; Frauke Naumann-Winter, PhD; Harald Enzmann, MD Aim: To provide a systematic overview on: i) safety profiles; ii) pharmacokinetic parameters; and iii) regulatory framework of anti-cancer tyrosine kinase inhibitors (TKI). Methodology: Recherché of pharmakokinetic (PK)-parameter: i) Germany’s federal drug database…

Author(s): Bodo Haas, PhD, Christoph Unkrig, MD, Frauke Naumann-Winter, PhD, Harald Enzmann, MD, Henrike Potthast, PhD, Lea Röper, BSc, Niels Eckstein, PhD, Ulrike Hermes, PhD

generics, narrow therapeutic index drugs, orphan drugs, product-specific bioequivalence guidance, tyrosine kinase inhibitors (TKI)

DOI: 10.5639/gabij.2014.0302.021