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

Author byline as per print journal: Toshihiko Hibino1, MD; Tomohiko Yoshida2, MD, PhD; Akira Sagawa3, MD, PhD; Ikuko Masuda4, MD, PhD; Takaaki Fukuda5, MD Introduction/Study objective: Needle fear is common among patients with rheumatoid arthritis (RA) who require subcutaneous (SC) injections. The convenience, usability and safety of the etanercept biosimilar YLB113 in an injection pen…

etanercept, injection pen, needle fear, rheumatoid arthritis, usability, YLB113

DOI: 10.5639/gabij.2020.0903.018

Abstract: Regulatory standards for recombinant DNA (rDNA)-derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their success as highly eff ective medicines. As biologicals and biosimilars are increasingly developed, licensed and used worldwide less experienced manufacturers and regulatory agencies need support…

Author(s): Elwyn Griffiths, DSc, PhD

ASEAN, biologicals, biosimilars, GMP, regulatory harmonization

DOI: 10.5639/gabij.2020.0903.017

Editor's Letter

Published on 02 July 2020

What to look forward to in GaBI Journal, 2020, Issue 2

This issue of the GaBI Journal is being published as the global coronavirus 2 (SARS-CoV-2) pandemic is expanding rapidly in many areas of the world including in the United States of America, South America, Asia, and Africa. While there is no known effective vaccine or cure, preliminary results have suggested that some treatments approved for…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0902.008

Abstract: Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to approve biosimilar drugs and Europe has overall more approved biosimilars, whilst the US approved the first biosimilar in 2015. Whatever the market, there are a…

Author(s): GaBI Journal Editor

biosimilar, EMA, regulation, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2020.0902.015