Contents Editor’s Letter What to look forward to in GaBI Journal, 2018, Issue 2 Commentary Potential changes to the FDA approach to biosimilars have a global impact Original Research Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2 Review Article Protein heterogeneity and…

Editor's Letter

Published on 27 August 2018

What to look forward to in GaBI Journal, 2018, Issue 2

The second issue of the 2018 GaBI Journal volume is being published at a time of increasing uncertainty concerning trade, tariffs, regulations as well as international and even inter-ally co-operation. This issue contains manuscripts discussing some changes which are either being asked for, or which are already occurring, with the potential to increase the global…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0702.010

Submitted: 20 June 2018; Revised: 14 August 2018; Accepted: 18 August 2018; Published online first: 31 August 2018 The ageing population, longer life expectancies, and the increasing cost of drugs are expected to significantly increase the burden on healthcare systems in the coming years. To reduce this burden and increase access to new, innovative and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0703.026

Author byline as per print journal: G Castañeda-Hernández, PhD; L Carbajal-Rodríguez, MD; M Cerón-Rodríguez, MD; Professor LC Correa-González, MD; A Esquivel-Aguilar, PhD; SJ Franco-Ornelas, MD; JE García Ortiz, PhD; CM Hernández-Guadarrama, MD; JI Navarrete-Martínez, MD; Y Santillán-Hernández, MD; E Terreros-Muñoz, MD Abstract: Enzyme replacement therapy (ERT) is the first-line treatment for Gaucher disease (GD). The…

Author(s): A Esquivel-Aguilar, PhD, CM Hernández-Guadarrama, MD, E Terreros-Muñoz, MD, G Castañeda-Hernández, JE García Ortiz, PhD, JI Navarrete-Martínez, MD, L Carbajal-Rodríguez, MD, M Cerón-Rodríguez, MD, Professor LC Correa-González, MD, SJ Franco-Ornelas, MD, Y Santillán-Hernández

biosimilar, Gaucher disease, imiglucerase, non-originator imiglucerase, orphan drugs

DOI: 10.5639/gabij.2019.0802.008

Introduction and study objectives: Benefit-risk evaluations are essential throughout the life cycle of a drug to guarantee therapeutic efficacy for the authorized indications without an unacceptable incidence of adverse effects. To achieve this, a registry, assessment of adverse drug reactions (ADRs) and other pharmacovigilance (PhV) procedures are mandatory. Due to the inherent variability of bioproduction,…

Author(s): Francisco Fernández, MD, Matías Deprati, MD, Patricia Rodríguez Acedo, Eduardo Spitzer, BSc, Alvaro Romera, MD, Nadia Español, BSc

adverse drug reaction, bevacizumab, biosimilar, monoclonal antibodies, pharmacovigilance, safety profile

DOI: 10.5639/gabij.2018.0703.023

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Elwyn Griffiths, PhD, DSc; Niklas Ekman, PhD Abstract: Biosimilar medicines are being increasingly developed and used worldwide. Many regulatory agencies across the globe are assessing how policy and regulation can be adapted and developed to ensure that biosimilars can enter markets successfully, without affecting the safety…

Author(s): Elwyn Griffiths, DSc, PhD, Niklas Ekman, PhD, Robin Thorpe, PhD, FRCPath

ASEAN, biologicals, biosimilars, education, regulatory, similar biotherapeutic product

DOI: 10.5639/gabij.2018.0703.025

Author byline as per print journal: Rana Musa Ali Al-ali “Malkawi”, MSc; Wesal Salem Al Haqaish, BPharm; Hayel Obeidat, MD Abstract: The regulatory oversight of medicinal products in Jordan is the responsibility of the Jordan Food and Drug Administration (JFDA). In 2015, JFDA adopted biosimilar guidelines, which are similar to those used by the European…

Author(s): Hayel Obeidat, MD, Rana Musa Ali Al-ali “Malkawi”, MSc, Wesal Salem Al-haqaish, BPharm

biological, biosimilar, EMA, INN, Jordan FDA, regulation

DOI: 10.5639/gabij.2018.0702.016

Author byline as per print journal: Peter J Pitts, BA; Michael S Reilly, Esq Abstract: The World Health Organization should finalize its Biological Qualifier guidance. Distinguishable naming will allow quick and accurate tracing of the manufacturer, should adverse events occur and improve patient safety by reducing confusion and mishaps. This will ensure that developing nations, including…

Author(s): Michael S Reilly, Esq, Peter J Pitts, BA

Biological Qualifier (BQ), biosimilar, INN, medicines regulation, MENA (Middle East and North Africa)

DOI: 10.5639/gabij.2018.0703.021

Submitted: 6 May 2018; Revised: 7 May 2018; Accepted: 8 May 2018; Published online first: 18 May 2018 Data and market exclusivity for originator medicines in the European Union (EU) create a barrier to market entry for generic medicines. Legislation means that generics cannot reach the market for at least 10 years following the originator…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0702.019

Author byline as per print journal: Auxiliary Professor Antistio Alviz-Amador1, MSc, Pharmaceutical Chemist; Jairo E Mercado Camargo2, MSc; Marlene Duran-Lengua3, MSc, PhD, Bacteriologist Introduction: Moxifloxacin is a quinolone antibiotic often used to treat infections caused by Gram-positive bacteria that have developed resistance in Colombia in recent years. Objective: To evaluate the concentration of active ingredient and the antibacterial…

Author(s): Antistio Alviz-Amador, MSc, Jairo E Mercado Camargo, MSc, Marlene Duran-Lengua, MSc, PhD

antibiotic resistance, Colombia, E. coli, moxifloxacin, S. aureus

DOI: 10.5639/gabij.2018.0703.024

Abstract: Biosimilar drugs have suffered slow entrance and acceptance rates in the US market, due not only to common misperceptions among the public but also US Food and Drug Administration (FDA) licensing laws. This review offers nine major recommendations for the FDA to simplify how biosimilars are licensed and thus make biosimilars more accessible to…

Author(s): Adjunct Professor Sarfaraz K Niazi, PhD, SI, FRSB, FPAMS, FACB

analytical similarity, biosimilars, immunogenicity testing, pharmacokinetic profiling

DOI: 10.5639/gabij.2018.0702.018

Abstract: The first draft guidelines for copy biologicals were introduced in China back in 2014. The Technical Guideline was then updated and finalized in 2015. In this paper, how the Drug Registration Regulation (2007) pathway classifies therapeutic biologicals and the principles and challenges of the copy biologicals guideline are described. Submitted: 3 May 2018; Revised:…

Author(s): GaBI Journal Editor

biological, China, copy biological, regulation

DOI: 10.5639/gabij.2018.0702.015