Submitted: 29 December 2017; Revised: 5 January 2018; Accepted: 12 January 2018; Published online first: 19 January 2018 A recent comparison of generic drug markets [1] explores the history of generics substitution and bioequivalence policies in the US, in order to understand the barriers to implementing reform of generic drug policies. The history of generics…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.009

Submitted: 30 January 2018; Revised: 8 February 2018; Accepted: 12 February 2018; Published online first: 26 February 2018 The past year has once again been a busy one for the biosimilars industry. Important milestones achieved during 2017 were the biosimilar approvals of Renflexis (infliximab-abda), Cyltezo (adalimumab-adbm), Mvasi (bevacizumab-awwb), Ixifi (infliximab-qbtx) and Ogivri (trastuzumab-dkst), along with…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.008

Abstract: Although small molecule drugs still dominate the global pharmaceutical market in terms of numbers, biologicals are making a significant dent. However, the high cost of biologicals is putting increasing pressure on healthcare budgets, thus opening the door to biosimilars. With patents on originator biologicals expiring, biosimilars are expected to take an increasing share of…

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2018.0701.007

Author byline as per print journal: Johanna Andrea García Cortes, MSc; Francisco Javier Sierra Esteban, MSc Abstract: Colombia is in the process of implementing legislation to allow for the approval of biosimilar products so that they can enter the Colombian market. Three regulatory pathways for the submission of biotherapeutic products have been developed and were…

Author(s): Francisco Javier Sierra Esteban, MSc, Johanna Andrea García Cortes, MSc

abbreviated comparability, biotherapeutics approval, Colombia, INVIMA

DOI: 10.5639/gabij.2018.0701.006

Author byline as per print journal: Hajaj M Alhomaidan; Ali M Alhomaidan, PhD Abstract: This paper describes the differences in human embryonic stem cell regulations in several Christian countries across the world: Italy, Spain, the UK, Germany and the US. It discusses issues related to Catholic and Protestant countries and how the differences in religious…

Author(s): Ali M Alhomaidan, PhD, Hajaj M Alhomaidan

regulation, religion, stem cell

DOI: 10.5639/gabij.2018.0701.005

Author byline as per print journal: Gary L O’Brien1, BPharm, MPharm; Donal Carroll2, BSc (Hon) Pharmacy; Mark Mulcahy3, BComm, MSc, PhD; Valerie Walshe4, BA, MA, PhD; Professor Garry Courtney2, MB, FRCPI; Professor Stephen Byrne1, BSc (Hon) Pharmacy, PhD Background and aim: Biosimilar medicines are not considered exact replicas of originator biological medicines. As a result, prescribers…

Author(s): Professor Garry Courtney, MB, FRCPI, Professor Stephen Byrne, BSc (Hon) Pharmacy, PhD, Gary L O’Brien, BPharm, MPharm, Donal Carroll, BSc (Hon) Pharmacy, Mark Mulcahy, BComm, MSc, PhD, Valerie Walshe, BA, MA, PhD

biologicals, evidence-based, inflammatory bowel disease (IBD), secondary care, switching

DOI: 10.5639/gabij.2018.0701.004

Introduction/Study objectives: A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). API manufacturers generally register API information as a Drug Master File (DMF) directly to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Because DMFs require appropriate management by their registrants, it is important…

Author(s): Maki Matsuhama, MSc, Ryosuke Kuribayashi, PhD

active pharmaceutical ingredients, Drug Master File, generic drugs, globalization, stable supply

DOI: 10.5639/gabij.2018.0701.003

Abstract: Major cost savings are achievable in pharmacotherapy in the European Union since biosimilars to most best-selling biological medicinal products have been licensed. Unfortunately, the window of opportunity may be missed since neither national pricing, reimbursement and procurement systems nor prescribers are well prepared for biosimilars’ entry to the market. Submitted: 9 March 2018; Revised:…

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

automatic substitution, biosimilars, cost savings, interchangeability, payers, prescribers

DOI: 10.5639/gabij.2018.0701.002

Editor's Letter

Published on 10 January 2018

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

There are many frustrating differences between reality and what is possible in every aspect of life, including politics, economics, science and health. This issue begins with a Commentary by Adjunct Professor Pekka Kurki about the differences between what could be versus what has been done in the European Union (EU) to reduce biological drug costs.…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0701.001

Submitted: 19 June 2017; Revised: 5 September 2017; Accepted: 6 September 2017; Published online first: 19 September 2017 Introduction Comparative research on the European and US generic drug markets based on 2013 IMS data across 13 European countries with different generic drug policies has recently been accepted for publication in the Milbank Quarterly [1], and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.043

Submitted: 17 November 2017; Revised: 20 November 2017; Accepted: 22 November 2017; Published online first: 5 December 2017 The tumour necrosis factor (TNF) inhibitor infliximab is known to significantly improve the treatment of inflammatory autoimmune diseases such as Crohn’s disease, ulcerative colitis and rheumatoid arthritis. The high cost of biological originators, however, has meant that…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.042

Human immunodeficiency virus (HIV) patients in high-income countries are likely to accept the introduction of generic antiretroviral (ARV) drugs, according to a study carried out by researchers in Ireland [1]. Between July and August 2015, a survey of 66 patients was carried out in one-to-one interviews at St James Hospital, Dublin, Ireland. Descriptive and univariate…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.041