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

Author byline as per print journal: Karsten Roth, PhD; Hendrik Wessels, PhD; Josef Höfler, PhD; Ulrike Scholz, PhD; Dirk Lehnick, PhD Abstract: Pelmeg® is a biosimilar pegfilgrastim, which obtained European Union (EU) regulatory approval in September 2018, with marketing beginning in January 2019. A comprehensive analytical, functional and preclinical comparability programme demonstrated a high degree…

Author(s): Dirk Lehnick, PhD, Hendrik Wessels, PhD, Josef Höfler, PhD, Karsten Roth, PhD, Ulrike Scholz, PhD

biosimilar, filgrastim, Neulasta®, pegfilgrastim, Pelmeg®, targeted development

DOI: 10.5639/gabij.2020.0903.021

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Associate Professor Sia Ming Kian, BSc (Pharm) (Hons); Chan Lai Wah, BSc (Pharm) (Hons), PhD Abstract: Biopharmaceuticals belong to a class of medicinal products whose active pharmaceutical ingredient (API) is manufactured using living systems such as microbial and mammalian cells.…

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Sia Ming Kian, BSc (Pharm) (Hons)

ASEAN, biopharmaceutical manufacturing, biopharmaceuticals, good manufacturing practice, harmonization, regulatory guidelines

DOI: 10.5639/gabij.2020.0902.010

Abstract: Clinical trials must demonstrate biosimilarity for regulatory marketing approval to be granted. The GaBI Journal has conducted a search for clinical trials that have been, or are being, carried out for trastuzumab biosimilars. Submitted: 26 March 2020; Revised: 2 April 2020; Accepted: 2 April 2020; Published online first: 15 April 2020 Roche’s originator trastuzumab…

Author(s): GaBI Journal Editor

biosimilar, clinical trials, trastuzumab

DOI: 10.5639/gabij.2020.0902.014

Author byline as per print journal: Professor John-Joseph Borg, PhD; Yolanda Elias Gramajo, MD; Professor Andrea Laslop, MD; Robin Thorpe, PhD, FRCPath; Jian Wang, MD, PhD Introduction: Biosimilars have the potential to improve access to medicines for many across the globe. However, work is required to ensure adequate regulation, pharmacovigilance and education about biosimilars. Colombia…

Author(s): Jian Wang, MD, PhD, Professor Andrea Laslop, MD, Professor John-Joseph Borg, Robin Thorpe, PhD, FRCPath, Yolanda Elias Gramajo, MD

biologicals, biosimilars, Colombia, INVIMA

DOI: 10.5639/gabij.2020.0903.022

Abstract: Iran was the first country in the MENA (Middle East and North Africa) region to publish a legal framework for the registration of biosimilars. This framework is defined by the Iranian Food and Drug Administration (IFDA). It defines biosimilars as biological products that have the same Active Pharmaceutical Ingredient (API) as the Reference Medicinal…

Author(s): Jalal Naeli, MD

biopharmaceuticals, Iran, reference medicinal product

Author byline as per print journal: Esteban Ortiz-Prado1,2, MD, MSc, MPH, PhD; Jorge Ponce-Zea3, MSc; Jorge E Vasconez1, MD; Diana Castillo,1, MD; Diana C Checa-Jaramillo1, MD; Nathalia Rodrí­guez-Burneo1, MD; Felipe Andrade2, MD; Damaris P Intriago-Baldeón4, MSc; Claudio Galarza-Maldonado5, MD, PhD Abstract: The number of approved biological medicines in the global pharmaceutical market has increased in…

biologicals, biopharmaceuticals, biosimilars, Latin America

DOI: 10.5639/gabij.2020.0902.011