Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 CT-P13, also known by its brand names Remsima or Inflectra, is a biosimilar of the infliximab reference product (RP) Remicade. CT-P13 is approved in Europe, the US and elsewhere for use in all indications for which the…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.023

Contents Editor’s Letter Editor’s introduction to the initial issue of the fifth volume of GaBI Journal Letters to the Editor First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society Commentary Low-cost generic drug programs in the US: implications for payers and researchers Waiver of consent for retrospective chart review studies Original…

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI Journal) in 2015. Professor Saleh Alsuwayeh, Saudi Arabia Professor Moses Chow, USA Associate Professor Joshua P Cohen, USA Professor Theodor Dingermann, Germany Dr Niklas Ekman, Finland…

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI Journal) in 2014. Ms Arpah Abas, Malaysia Dr Christoph Baumgärtel, Austria Professor Daniel Kelly Benjamin Jr, USA Professor Gerrit Borchard, Switzerland Dr Chiann Chang, Brazil…

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI Journal) in 2013. Dr Ibrahim Aljuffali, Saudi Arabia Professor Saleh Alsuwayeh, Saudi Arabia Professor Alain Astier, France Dr Christoph Baumgärtel, Austria Professor Mohamed Izham Bin…

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI Journal) in 2012. Ms Arpah Abas, Malaysia Dr Ibrahim Alshwaier, Saudi Arabia Professor Saleh Alsuwayeh, Saudi Arabia Dr Christoph Baumgärtel, Austria Professor Daniel Benjamin, USA…

Author byline as per print journal: Luther Gwaza1,2, BPharm, MPhil; John Gordon3, PhD; Henrike Potthast4, PhD; Marc Maliepaard5, PhD; Jan Welink5, Hubert Leufkens1,5, PhD; Matthias Stahl6, MD; Alfredo García-Arieta7, PhD Abstract: Generic medicines are approved by regulatory authorities based on demonstration of bioequivalence with the innovator, however, direct comparison between all available generics of the…

Author(s): Alfredo García Arieta, PhD, Henrike Potthast, PhD, Hubert Leufkens, PhD, Jan Welink, John Gordon, PhD, Luther Gwaza, BPharm, MPhil, Marc Maliepaard, PhD, Matthias Stahl, MD

adjusted indirect comparisons, bioequivalence, drug switching, generic medicines, interchangeability, prequalification

DOI: 10.5639/gabij.2016.0502.015

Editor's Letter

Published on 04 May 2016

Editor’s introduction to the initial issue of the fifth volume of GaBI Journal

This issue begins with a Letter to the Editor by Professor Fabio V Teixeira from the Brazilian Inflammatory Bowel Disease (IBD) Society that deals basically with the issue of extrapolation of indications. The letter states that ‘vigilance remains essential’ for the use of this agent in IBD patients. Professor Teixeira’s letter is in response to…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0501.001

Author byline as per print journal: Valderílio Feijó Azevedo1,2, Alejandra Babini3,4, Fabio Vieira Teixeira5,6, Igor Age Kos1,2, Pablo Matar7 Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, to present and discuss recent…

Author(s): Alejandra Babini, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Igor Age Kos, Pablo Matar, PhD, Professor Fabio V Teixeira, MSc, MD, PhD

biosimilarity, extrapolation, infliximab, interchangeability, monoclonal antibodies, rituximab

DOI: 10.5639/gabij.2016.0502.017

Abstract: The importance of obtaining IRB/EC consent for waiver of consent before embarking on retrospective chart review studies was highlighted using the recent case of a manuscript submitted to GaBI Journal. Submitted: 12 March 2016; Revised: 14 March 2016; Accepted: 14 March 2016; Published online first: 28 March 2016 This commentary was prompted by a…

Author(s): Professor Philip D Walson, MD

chart review, consent, retrospective, waiver

DOI: 10.5639/gabij.2016.0501.004

Submitted: 29 February 2016; Revised: 15 March 2016; Accepted: 16 March 2016; Published online first: 29 March 2016 Use of brand name drugs over generic equivalents after expiration of exclusivity still prevails. Ameet Sarpatwari and Aaron Kesselheim argue the case for reforming drug naming by allowing generic products to share the brand names of their…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.012

Abstract: This paper describes the existing European Union legislation and scientific guidance to adequately assess the quality, safety and efficacy, as well as the lifecycle management, of the group of non-biological complex drug (NBCD) products, including nanomedicines such as liposomes, polymeric micelles, glatiramoids and iron-carbohydrate complexes. Submitted: 15 March 2016; Revised: 1 April 2016; Accepted:…

Author(s): Falk Ehmann, MD, PhD, MSc, Ruben Pita, PharmD, LLM

complex pharmaceutical forms, EMA, nanomedicines, regulatory science

DOI: 10.5639/gabij.2016.0501.008