Author byline as per print journal: Joan O’Callaghan, BSc Pharm; Sean Barry, PhD; Una Moore, PhD; Margaret Bermingham, PhD; J Michael Morris, PhD; Frank Hallinan, PhD; Brendan T Griffin, PhD Abstract: Regulatory Science Ireland (RSI) is a voluntary network of interested parties from academia, the Health Products Regulatory Authority (HPRA), pharmaceutical and medical device industries and government…

Author(s): Brendan T Griffin, PhD, Frank Hallinan, PhD, J Michael Morris, PhD, Joan O’Callaghan, BSc Pharm, Margaret Bermingham, PhD, Sean Barry, PhD, Una Moore, PhD

biological medicines, biosimilar, Health Products Regulatory Authority, regulatory science, Regulatory Science Ireland

DOI: 10.5639/gabij.2016.0504.043

Author byline as per print journal: Shyam Akku, MD; Amit Garg, MD; Suhas Khandarkar, MPharm Introduction: Majority of the Colombian population has become health insured leading to improved healthcare access in the country. Healthcare expenses have risen drastically, and cancer is responsible for the major disease burden. An option to reduce cost burden is to replace…

Author(s): Amit Garg, MD, Shyam Akku, MD, Suhas Khandarkar, MPharm

anticancer drugs, cost-minimization, generics, pharmacoeconomics

DOI: 10.5639/gabij.2016.0504.042

Author byline as per print journal: Babar Khan, BPharm, MPH, PhD; Brian Godman, BSc, PhD; Ayesha Babar, BPharm, MPhil; Shahzad Hussain, BPharm, MPhil; Sidra Mahmood, PharmD, MSc; Tahir Aqeel, BPharm, MPhil Introduction: There are concerns over the quality of generic medicines in Pakistan. This is due to perceived non-compliance with good manufacturing practice (GMP), whereby the…

Author(s): Ayesha Babar, BPharm, MPhil, Babar Khan, BPharm, MPH, PhD, Brian Godman, BSc, PhD, Shahzad Hussain, BPharm, MPhil, Sidra Mahmood, PharmD, MSc, Tahir Aqeel, BPharm, MPhil

API (active pharmaceutical ingredient), Drugs Regulatory Authority, generics, ibuprofen, Pakistan

DOI: 10.5639/gabij.2016.0504.041

Author byline as per print journal: Professor Philip J Schneider, MS, FASHP; Michael S Reilly, Esq Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance on the naming of biosimilar medicines. The Alliance for Safe Biologic Medicines (ASBM) has asked pharmacists for their views on the labelling and naming of…

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP

ASBM, biologicals, biosimilars, labelling, naming, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2016.0504.040

Abstract: Physicians are pondering the clinical use of biosimilars. A reliance on clinical trials is deeply rooted in the modern healthcare system, whereas comparability and totality of evidence remain unknown concepts. This editorial explores these ideas, with reference to a case study of Italian gastroenterologists. Submitted: 24 October 2016; Revised: 1 November 2016; Accepted: 1…

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

biosimilars, NOR-SWITCH, totality of evidence

DOI: 10.5639/gabij.2016.0504.039

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: A study of the factors influencing generics makers’ decision on whether to enter a specific market found that firm size, market revenue and expected competition all had an effect. Market size was also positively associated with the entry of more generics. The effect of a financial subsidy on generics entry was also investigated. Submitted:…

Author(s): GaBI Journal Editor

financial subsidy, generics entry, generics market, price competition

DOI: 10.5639/gabij.2016.0503.037

Abstract: There is considerable concern and debate over the naming of biologicals and labelling of biosimilars. To ensure that patients receive the safest and most effective treatment, it is paramount that clinicians, prescribers and patients themselves have the relevant information regarding drug treatment. In response to concerns over how biologicals and biosimilars should be named…

Author(s): GaBI Journal Editor

biologicals, biosimilars, labelling, naming, nomenclature, regulation

DOI: 10.5639/gabij.2016.0503.036

Abstract: The US Food and Drug Administration (FDA) outlines its approach to biosimilarity and interchangeability at the 2016 Generic Pharmaceutical Association Biosimilars Council Conference. Topics covered include the FDA definition of biosimilarity, its step-wise approach to the approval process and factors/issues that should be considered when providing scientific justification for extrapolation. Submitted: 22 September 2016;…

Author(s): GaBI Journal Editor

biologicals, biosimilar, biosimilarity, interchangeability, regulation

DOI: 10.5639/gabij.2016.0503.035

Abstract: This paper discusses the findings and summary of items covered in the First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, in which structure–function was highlighted as a key issue. Submitted: 4 June 2016; Revised: 7 September 2016; Accepted: 15 September 2016; Published online first: 28 September 2016 Introduction This interactive…

Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath

glycosylation, immunogenicity, potency, receptor binding, serum half-life, sialic acid

DOI: 10.5639/gabij.2016.0503.034

Author byline as per print journal: Vito Annese, MD; Tommaso Gabbani, MD; Antonio Luca Annese, MD Abstract: The introduction of biological therapy has revolutionized the paradigm of treatment in the last two decades. This is expected to lead to corresponding amelioration of the course of several immune-mediated diseases, including inflammatory bowel diseases (IBD). However, this…

Author(s): Antonio Luca Annese, MD, Tommaso Gabbani, MD, Vito Annese, MD

adalimumab, biosimilar, Crohn’s disease (CD), inflammatory bowel disease (IBD), switching, ulcerative colitis (UC)

DOI: 10.5639/gabij.2016.0503.033

Introduction: Canada is among the leading spenders in pharmaceuticals. Based on projected figures, the cost of pharmaceuticals is expected to rise by another 6–12% by 2023. Approximately CAN$4.6 billion of healthcare funding is spent on biological drugs (including growth factors and monoclonal antibodies) which are commonly used in the setting of haematology and blood and…

Author(s): Cherie C Severson, RN, MN, CON(C), BMTCN

biologicals, biosimilars, blood and marrow transplant, cost, haematology, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0503.032