Author byline as per print journal: Stuart Bloom, DM, FRCP; Keith Bodger, MBChB(Honours), MD, FRCP; Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP; Professor Sarah Garner, BPharm, PhD; Professor Kimme Hyrich, MD, PhD, FRCPC; Clare Jacklin; Professor John G Williams, CBE, FRCP Introduction: Registries collect clinical data to evaluate specified outcomes for a population defined by a particular disease, condition…

Author(s): Clare Jacklin, Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP, Keith Bodger, MBChB(Honours), MD, FRCP, Professor John G Williams, CBE, FRCP, Professor Kimme Hyrich, MD, PhD, FRCPC, Professor Sarah Garner, BPharm, PhD, Stuart Bloom, DM, FRCP

biologicals, biosimilars, monoclonal antibodies, pharmacovigilance, registries, regulation

DOI: 10.5639/gabij.2017.0603.025

Introduction/Study objective: This paper aims to survey the policies implemented by European countries for pricing and promoting the use of biosimilar medicines and to explore similarities and differences with policies for generic medicines. Methods: A literature review was supplemented by primary data collection with policymakers. Members of the Pharmaceutical Pricing and Reimbursement Information (PPRI) network,…

Author(s): Peter Schneider, MA, Sabine Vogler, PhD

biosimilar, generics, policy, pricing, substitution, tender

DOI: 10.5639/gabij.2017.0602.015

Author byline as per print journal: Brian Godman, BSc, PhD; Claudia Wild, PhD; Alan Haycox, PhD Abstract: Venkatesan S et al. have researched patent rights and pricing for (non-)tyrosine kinase inhibitors. It is not clear why the patent rights are so long and why prices of (non-)tyrosine kinase inhibitors can be high. These issues are discussed.…

Author(s): Alan Haycox, PhD, Brian Godman, BSc, PhD, Claudia Wild, PhD

cancer medicines, generics, health gain, prices, tyrosine kinase inhibitors (TKI)

DOI: 10.5639/gabij.2017.0603.021

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 2016. Dr Ali M Alhomaidan, Saudi Arabia Dr Srinivas Chollangi, USA Professor Joshua Cohen, USA Professor Daan J Crommelin, The Netherlands Professor Theodor…

Author byline as per print journal: Jean-Baptiste Reiland, MSc; Barbara Freischem; Alexander Roediger, MA Introduction/Study objective Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the first biosimilar was approved in the European Union (EU), but…

Author(s): Alexander Roediger, MA, Executive MBA, Barbara Freischem, Jean-Baptiste Reiland, MSc

biological medicines, biosimilars, off-patent market, pricing and reimbursement policy

DOI: 10.5639/gabij.2017.0602.014

Editor's Letter

Published on 08 March 2017

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

This first issue of 2017 includes a range of manuscripts of interest to readers. A Letter to the Editor from Professor Mohamed Izham Mohamed Ibrahim and Nada Moustafa Abdel Rida proposes steps that governments and international organizations have taken or need to do, especially with respect to pricing of pharmaceuticals, to make ‘Essential Medicines’ more…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0601.001

Abstract: Clinical evidence supporting biosimilar use is growing and for the first time, the Austrian Medicines and Medical Devices Agency takes a positive position on interchangeability. They now state that prescribing biosimilars to treatment-naïve patients and even a change from originator to biosimilar is appropriate, provided it is done under physician’s supervision. Submitted: 9 January…

Author(s): Christoph Baumgärtel, MD, MSc

Austria, biosimilars, interchangeability

DOI: 10.5639/gabij.2017.0601.009

Author byline as per print journal: Professor Francisco José de Abajo, MD, MPH, PhD; Professor Joan Albanell, MD; Olga Delgado Sanchez, PharmD; Kevin Klein, MSc; José Vicente Moreno-Muelas, MD; Sol Ruiz, PhD; Professor Maria Jesús Sanz Ferrando, PhD; Robin Thorpe, PhD, FRCPath; Professor Francisco Zaragozá, PhD Introduction: Biosimilars can offer a lower-cost alternative to current biological therapies and could…

Author(s): José Vicente Moreno-Muelas, MD, Kevin Klein, PhD, Olga Delgado Sanchez, PharmD, Professor Francisco José de Abajo, MD, MPH, PhD, Professor Francisco Zaragozá, PhD, Professor Joan Albanell, MD, Professor Maria Jesús Sanz Ferrando, PhD, Robin Thorpe, PhD, FRCPath, Sol Ruiz, PhD

biologicals, immunogenicity, interchangeability, pharmacovigilance, Spain, traceability

DOI: 10.5639/gabij.2017.0601.007

Submitted: 27 January 2017; Revised: 31 January 2017; Accepted: 1 February 2017; Published online first: 6 February 2017 Previous years have been momentous for biosimilars [1] and 2016 is no exception. This paper highlights the various developments that have taken place during 2016 for biosimilars. Important milestones achieved during 2016 were the biosimilar approvals of…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0601.010

Submitted: 19 January 2017; Revised: 20 January 2017; Accepted: 23 January 2017; Published online first: 6 February 2017 In an article published in US Pharmacist [1] Manigault et al. emphasize a number of barriers that still exist to effective generics substitution in the US, and show how pharmacists, with some knowledge and insight, can help…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0602.019

Abstract: Biosimilars have been approved in Europe since 2006 and in the US since 2015. With patents on originator biologicals expiring and ever-tightening healthcare budgets, biosimilars are expected to take an increasing share of the biologicals market. In light of these facts, this paper gives estimated patent expiry dates for just some of the best-selling…

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2017.0601.006

Author byline as per print journal: Anu Gore, PhD; Mayssa Attar, PhD; Chetan Pujara, PhD; Sesha Neervannan, PhD Abstract: Generic drugs are intended to provide a lower cost option of safe and effective medicines thereby granting greater patient access to affordable health care. A sound scientific basis and a robust regulatory process to demonstrate bioequivalence of…

Author(s): Anu Gore, PhD, Chetan Pujara, PhD, Mayssa Attar, PhD, Sesha Neervannan, PhD

dry eye, ocular, ophthalmic, safety, topical

DOI: 10.5639/gabij.2017.0601.004