Author byline as per print journal: Josette Sciberras, MBA, MA Bioethics, BPharm (Hons); Raymond Zammit, SThD; Patricia Vella Bonanno, PhD Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and…

biological medicines, European intellectual property rights, market access, pricing, R & D

DOI: 10.5639/gabij.2021.1004.022

Author byline as per print journal: Lyndsay Davies1, PhD; Katie Milligan1, BSc; Mark Corris1, BSc; Ian Clarke1; Paul Dwyer1, MSc; Sarah Elizabeth Lee2, PhD; Jolene Teraoka3, BSc; Jill Crouse-Zeineddini3, PhD; Jane Hippenmeyer4, PharmD Study Objectives: To investigate the quality and in-use stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in both concentrated multi-dose bags and following…

biosimilar, elastomeric device, KANJINTI® ABP 980, stability, trastuzumab

DOI: 10.5639/gabij.2021.1004.021

Editor's Letter

Published on 29 September 2021

Latest features in GaBI Journal, 2021, Issue 3

This issue of GaBI Journal contains articles dealing with some very practical issues related to the evaluation, describing, and use of generic and biosimilar products. These issues include the uncertainty associated with extrapolating results of studies that used small, non-representative study populations, study sites, or product types. These problems are evident in the evaluation of…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1003.012

Contents Editor’s Letter Latest features in GaBI Journal, 2021, Issue 3 Original Research Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study Review Article A critical review of substitution policy for biosimilars in Canada Microbiological, scientific and regulatory perspectives of hand sanitizers…

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory…

DOI: 10.5639/gabij.2021.1003.015

Author byline as per print journal: Michael Wilcock, MPhil; Andrew Pothecary, MSc Introduction: Biological medicines are used to treat a range of conditions according to National Institute for Health and Care Excellence (NICE) technology appraisals. The annual drug treatment cost per patient per year varies depending on various factors, including newer or older biological, and…

biologicals, biosimilars, dermatology, psoriasis

DOI: 10.5639/gabij.2021.1003.018

Author byline as per print journal: Nishalini Harikrishnan1, BSc; Ka-Liong Tan2, DPhil; Kar Ming Yee3, BPharm; Alia Shaari Ahmad Shukri1, MSc; Nalla Ramana Reddy4, MBBS; Chuei Wuei Leong3, PhD Introduction/Study Objectives: A bioequivalence study was performed to compare the pharmacological profile of innovator etoricoxib (ETO) with a newly developed generic ETO, both in a 120…

bioequivalence, COX-2 inhibitor, etoricoxib, generics

DOI: 10.5639/gabij.2021.1003.013

Author byline as per print journal: Professor Philip J Schneider1, MS, FASHP, FASPEN, FFIP; Michael S Reilly2, Esq Canada has approved a total of 36 biosimilars. While the approval of biosimilars is regulated at the national level, decisions about biosimilar substitution are made at the provincial level. Four Canadian provinces, representing around 50% of the…

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

biosimilars, Canada, policy, substitution, switching

DOI: 10.5639/gabij.2021.1003.016

Submitted: 14 May 2021; Revised: 14 May 2021; Accepted: 3 June 2021; Published online first: 10 June 2021 Medicines regulatory authorities aim to address rising healthcare costs and promote access to medicines worldwide through review and approval of quality generic drug products that are interchangeable with the corresponding reference medicinal product. The Bioequivalence Working Group…

Author(s): Alfredo García Arieta, PhD, Clare Rodrigues

DOI: 10.5639/gabij.2021.1003.019

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Tan Ying Ting, BSc Pharm (Hons); Associate Professor Chan Lai Wah, BSc Pharm (Hons), PhD Hand sanitizers are rub-on formulations for the purpose of inactivating microorganisms on the hands. With the recent COVID-19 pandemic, a surge in the manufacturing, sale…

effectiveness, hand sanitizers, myths, regulatory framework, safety, standards

DOI: 10.5639/gabij.2021.1003.017

Contents Editor’s Letter What to look forward to in GaBI Journal, 2021, Issue 2 Original Research Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation Biosimilars in Saudi Arabia: a single-centre, open-label case series examining infliximab switching Variation in the prices of oncology medicines across Europe and the implications for the future Review…

Submitted: 15 March 2021; Revised: 17 March 2021; Accepted: 18 March 2021; Published online first: 24 March 2021 Cancer is one of the leading causes of mortality in the world today. The development of new drugs can reduce death rates, but these products are extremely expensive in terms of development time and money. This has…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2021.1002.011