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

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s fifth volume Editorial Physicians, Hippocrates and biosimilars: applying ancient principles in a modern society Original Research Naming and labelling of biologicals – the perspective of hospital and retail pharmacists Assessment of active pharmaceutical ingredients in drug registration procedures in Pakistan: implications for the future Review…

Abstract: How has the European Medicines Agency (EMA) changed its requirements for biosimilars since it first approved biosimilars in 2006? This is the question Dr Martina Weise, Head of Licensing Division at the Federal Institute for Drugs and Medical Devices (BfArM), discussed at the 14th Annual Biosimilar Medicines Group Conference. Submitted: 1 December 2016; Revised:…

Author(s): GaBI Journal Editor

biosimilar, biosimiliarity, data requirements, extrapolation

DOI: 10.5639/gabij.2016.0504.047

Editor's Letter

Published on 16 December 2016

Fourth and final issue of GaBI Journal’s fifth volume

This fourth and final GaBI Journal issue of 2016 begins with the paper by Adjunct Professor Pekka Kurki about ‘applying ancient principles in a modern society’ in which he discusses a perspective recently published in our journal from Annese et al. that presented the skeptical views expressed by Italian gastroenterologists concerning extrapolation of indications for…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0504.038

Abstract: In 2016, a multi-stakeholder workshop was held on the topic of ‘Biosimilar Labelling’. The discussions concerning labelling particulars are outlined in this meeting report. Submitted: 21 November 2016; Revised: 23 January 2017; Accepted: 24 January 2017; Published online first: 6 February 2017 Introduction Labels on medicinal products contain information for pharmacists, physicians and patients.…

Author(s): GaBI Journal Editor

biosimilar, labelling, patients, pharmacists, physicians, Summary of Product Characteristics (SmPC)

DOI: 10.5639/gabij.2017.0601.008

Author byline as per print journal: Subramanian Venkatesan, MSc; Associate Professor Martine Lamfers, PhD; Professor Sieger Leenstra, MD, PhD; Professor Arnold G Vulto, PharmD, PhD, FCP Abstract: Kinase inhibitors form the largest class of novel anticancer drugs. To date, more than 20 kinase inhibitors have been approved for clinical use. Lengthy patent rights keep the cost…

Author(s): Associate Professor Martine Lamfers, PhD, Professor Arnold G Vulto, PharmD, PhD, FCP, Professor Sieger Leenstra, MD, PhD, Subramanian Venkatesan, MSc

anticancer drugs, kinase inhibitors, market exclusivity, patent expiry, targeted therapies

DOI: 10.5639/gabij.2017.0602.016

Author byline as per print journal: Barbara OM Claus, PharmD, PhD; Tiene Bauters, PharmD, PhD; Annemie Somers, PharmD, PhD Abstract: In the coming decade, many patents for biological pharmaceuticals will expire. Consequently, the market for biosimilars has the potential to grow rapidly. For safety reasons, the more extensive use of a greater variety of biologicals increases…

Author(s): Barbara OM Claus, PharmD, PhD, Professor Annemie Somers, PharmD, PhD, Tiene Bauters, PharmD, PhD

biologicals, biosimilars, hospitals, pharmacovigilance

DOI: 10.5639/gabij.2017.0601.005