Abstract: The first draft guidelines for copy biologicals were introduced in China back in 2014. The Technical Guideline was then updated and finalized in 2015. In this paper, how the Drug Registration Regulation (2007) pathway classifies therapeutic biologicals and the principles and challenges of the copy biologicals guideline are described. Submitted: 3 May 2018; Revised:…

Author(s): GaBI Journal Editor

biological, China, copy biological, regulation

DOI: 10.5639/gabij.2018.0702.015

Abstract: High resolution analytical techniques reveal structural micro-heterogeneity within endogenous proteins, however, they are ‘seen’ as ‘self’ molecules by the immune system and immunological tolerance is established. In contrast the protein biotherapeutics are produced in non-human cells and multiple downstream protocols are employed in the isolation and purification of drug product; consequent micro-heterogeneities may be…

Author(s): Professor Roy Jefferis, PhD, DSc, MRCP, FRCPath

allotypes, erythropoietin, human IgG, idiotypes, immunogenicity, polymorphisms, post-translational modifications, structural heterogeneity

DOI: 10.5639/gabij.2018.0702.013

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

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

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

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: 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

Abstract: Biosimilar medicines are having a global effect, and as such regulatory agencies worldwide are assessing how to respond to them. Here, two events held by GaBI for the Colombian medicines regulatory agency (INVIMA) are reported. The first was an educational workshop held in 2016 to discuss approaches to evaluating biosimilar products and the second…

Author(s): Elaine Gray, PhD, Paul Matejtschuk, PhD, CChem, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, Colombia, quality assessment, regulatory

DOI: 10.5639/gabij.2018.0702.017

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

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

Author byline as per print journal: Victoire Vieillard, PharmD; Professor Alain Astier, PharmD, PhD; Muriel Paul, PharmD Objectives: This study assessed the long-term stability of the trastuzumab biosimilar CT-P6 (Herzuma®, Biogaran) in vials under various storage conditions; after reconstitution of the lyophilized powder (21 mg/mL) and after dilution for final concentrations of 0.8 mg/mL and 2.4…

Author(s): Muriel Paul, PharmD, Professor Alain Astier, PharmD, PhD, Victoire Vieillard, PharmD

biosimilar, extended stability, in-use stability, trastuzumab

DOI: 10.5639/gabij.2018.0703.022