Author byline as per print journal: Kelly Canham1, BSc Hons; Claire Newcomb2, MSc Introduction/Study Objectives: Etanercept is a tumour necrosis factor inhibitor indicated for the treatment of several inflammatory disorders. Patients with these diseases may experience manual dexterity challenges. Autoinjectors may improve dose accuracy, treatment adherence and quality of life; and reduce injection-site reactions. Studies…

autoinjector, biosimilar, etanercept, usability, YLB113

DOI: 10.5639/gabij.2021.1002.006

Abstract: In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed. Submitted: 12 October 2020; Revised: 28 October 2020; Accepted:…

Author(s): Madelaine A Feldman, MD, FACR, Michael S Reilly, Esq

biosimilars, competition, FDA, market share, sustainability, US

DOI: 10.5639/gabij.2020.0904.025

Contents Editor’s Letter Latest features in GaBI Journal, 2020, Issue 3, 2020, Issue 3 Commentary Quality standards for biopharmaceuticals: the importance of good manufacturing practice Original Research Qualitative survey-based evaluation of operability and convenience for the etanercept biosimilar YLB113 in a unique injection pen in patients with rheumatoid arthritis Systematic analysis of injection-site pain and…

Abstract: This editorial highlights the importance of carrying out comparative studies of patient tolerance to biosimilars and originator products. Minor side effects can affect their acceptability. Submitted: 23 September 2020; Revised: 2 October 2020; Accepted: 6 October 2020; Published online first: 12 October 2020 The previous issue of GaBI Journal published a manuscript entitled ‘Systematic…

Author(s): Professor Alain Astier, PharmD, PhD

DOI: 10.5639/gabij.2020.0904.024

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, MSc, PhD; Hye-Young Kwon, PhD1,6 Abstract: There is an increasing need to prescribe biosimilars to fund new medicines and increasing medicine volumes. Bertolani and Jommi document successful measures introduced regionally in Italy. The recent GaBI Journal manuscript by Bertolani…

Author(s): Brian Godman, BSc, PhD, Eleonora Allocati, BSc, MSc, Evelien Moorkens, BSc, MSc, Hye-Young Kwon, BPharm, MPH, PhD

biosimilars, demand-side measures, educational initiatives, Italy, savings

DOI: 10.5639/gabij.2020.0904.029

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Vernon Tay1, BSc (Pharm) (Hons); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm) (Hons), PhD Abstract: Data Integrity, which is data deemed Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA-plus), has been the focus of…

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Vernon Tay, BSc (Pharm) (Hons), Vimal Sachdeva, MSc

ALCOA-plus, audit trail, blockchain technology, computerized system, cooperation, data integrity

DOI: 10.5639/gabij.2020.0904.028

Editor's Letter

Published on 22 September 2020

Latest features in GaBI Journal, 2020, Issue 3

The Commentary in this issue of the GaBI Journal by Dr Elwyn Griffiths discusses the need for more global harmonization of regulatory approaches to biological medicines. Dr Griffiths refers to the conclusions of the GaBI organized ASEAN (Association of Southeast Asian Nation) conference on this topic. Similar calls have however come from participants in other…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0903.016

Author byline as per print journal: Jolita Seckute1, PhD; Ingrid Castellanos2, PhD; Steven Bane1, PhD Study Objectives: To evaluate extended in-use stability of bevacizumab biosimilar, ABP 215, after dilution into intravenous bags, extended storage, and simulated infusion to enable advanced preparation and storage. Methods: Two lots of ABP 215 were diluted to high- (16.5 mg/mL)…

ABP 215, administration, bevacizumab, biosimilar, infusion, stability

DOI: 10.5639/gabij.2020.0904.026

Author byline as per print journal: Arianna Bertolani, PhD; Claudio Jommi, MS Study Objectives: Different policies have been implemented to enhance uptake of biosimilars. Regarding policies focussing on the demand-side, the literature has mainly concentrated on interchangeability and substitutability recommendations, issued by national or regional policymakers. Information on actions taken by healthcare organisations (HCOs) regarding…

Author(s): Arianna Bertolani, PhD, Claudio Jommi, MS

biosimilars, Italian national health service, local policies

DOI: 10.5639/gabij.2020.0904.027

Author byline as per print journal: Rieke Alten1, MD, PhD; Herbert Kellner2, MD; Malcolm Boyce3, MD; Takuma Yonemura4, MD; Takahiro Ito5, MSc; Mark C Genovese6, MD Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated biosimilarity between FKB327 and the reference product in…

adalimumab, anti-TNF therapy, biosimilars, clinical trials, injection-site pain, rheumatoid arthritis

DOI: 10.5639/gabij.2020.0903.019

Contents Editor’s Letter What to look forward to in GaBI Journal, 2020, Issue 2 Commentary Importance of the determination of the higher order structure in the in-use stability studies of biopharmaceuticals Review Article Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals Current trends for biosimilars in the…

Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars of 15 originator biological medicines have a marketing authorization in Europe. Now, for the second time, the Alliance for Safe Biologic Medicines (ASBM) asked European…

Author(s): Madelaine A Feldman, MD, FACR, Michael S Reilly, Esq

biological medicines, biosimilar, EU, prescribers, substitution, survey

DOI: 10.5639/gabij.2020.0903.020