Author byline as per print journal: Niklas Ekman, PhD; Professor Arnold G Vulto, PharmD, PhD; Paul Cornes, MD Abstract: The increasing cost of medicines was highlighted at the Biosimilar Medicines Group (formerly EBG) satellite symposium at the European Association of Hospital Pharmacists’ 2016 Vienna conference. Using biosimilars as a way to reduce pharmaceutical expenditure was…

Author(s): Niklas Ekman, PhD, Paul Cornes, MD, Professor Arnold G Vulto, PharmD, PhD, FCP

biological, biosimilar, cancer, European Union, healthcare costs, medicines, regulatory

DOI: 10.5639/gabij.2016.0502.020

Author byline as per print journal: Jorge Mestre-Ferrandiz, PhD; Adrian Towse, MA; Mikel Berdud, PhD Abstract: Payers need to think strategically in medium/long term to maximize benefits from biosimilars. Concerns about biosimilars’ interchangeability/substitution (with their reference product) and uncertainty about outcomes act as barriers for their uptake. This paper recommends a policy which provides: (1)…

Author(s): Adrian Towse, MA, Jorge Mestre-Ferrandiz, PhD, Mikel Berdud, PhD

biosimilars, competition, incentives, real world data, savings, value for money

DOI: 10.5639/gabij.2016.0503.027

Abstract: Adjusted indirect comparisons are valuable to establish the bioequivalence and thereby the interchangeability between generic drug products. Limitations should be observed especially when several generics of a drug are marketed. Submitted: 14 June 2016; Revised: 23 June 2016; Accepted: 24 June 2016; Published online first: 4 July 2016 A recent review discussed adjusted indirect…

Author(s): Professor Laszlo Endrenyi, PhD, DSc, Professor László Tóthfalusi, MSc, PhD

adjusted indirect comparisons, bioequivalence, generic drugs, generic medicines, interchangeability, switchability

DOI: 10.5639/gabij.2016.0502.014

Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 The introduction of biologicals has revolutionized the treatment of immune-mediated diseases such as rheumatoid arthritis (RA) [1]. However, in many countries, patient access to these agents is restricted due to their high costs [2, 3]. Biosimilar drugs…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.024

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