Contents Editor’s Letter Unmet potential of Generics and Biosimilars to reduce healthcare costs Original Research Pricing of oral generic cancer medicines in 25 European countries; findings and implications Review Article Are there biosimilar orphan drugs for Gaucher disease? An overview in Mexico Meeting Report 2nd MENA Stakeholder Meeting on Biosimilars 2018 – Report Abstracted Scientific…

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…

Editor's Letter

Published on 30 November 2020

Medical journal publication during global stress

This issue of the GaBI Journal is being published during one of the most turbulent periods in over a century. A deadly pandemic is raging, the global economy is stressed, and the negative impacts of global weather changes as well as both the number and impact of regional conflicts are all increasing rapidly. While these…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0904.023

Abstract:Drug development is among the highest producers of greenhouse gas (GHG) emissions, with about 4.4%–4.6% of the worldwide GHG emissions coming from the thousands of clinical trials being carried out annually by the pharmaceutical industry. In a world where environmental stewardship, social diversity, and equitable governance (ESG) are progressively becoming biomarkers of business purpose, adopting…

Author(s): Shivani Mittra, MPharm, PhD, Shylashree Baraskar, MBBS, Elena Wolff-Holz, MD, Sandeep N Athalye, MBBS, MD

biological, biosimilars, carbon footprint, clinical trials, ESG (Environmental Social Governance), sustainability

DOI: 10.5639/gabij.2024.1303.033

Contents Editor’s Letter Editor’s introduction to the initial issue of the ninth volume of GaBI Journal Original Research Stability of the trastuzumab biosimilar ABP 980 compared to reference product after intravenous bag preparation, transport and storage at various temperatures, concentrations and stress conditions Pharmaceutical pricing policy in Saudi Arabia: findings and implications Perspective An evolving…

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…

Abstract:This paper examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings (Sawai GHD) and other manufacturers. It provides a comprehensive analysis of the consequences stemming from lapses in good manufacturing practice (GMP) compliance, particularly highlighted by the case of teprenone capsules 50 mg…

Author(s): Takanao Hashimoto, PhD, Akihiko Ozaki, MD, PhD, Hiroaki Saito, MD, Erika Yamashita, Tetsuya Tanimoto, MD, Professor Mihajlo Jakovljevic, MD, PhD, MAE

COVID-19 pandemic, drug shortages, generic drugs, good manufacturing practice, pharmaceutical policy

DOI: 10.5639/gabij.2024.1303.036

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Fluorouracil Accord 50 mg/mL solution for injection or infusion in three different types of elastomeric infusion pumps over 42 days, either undiluted (50 mg/mL) or after dilution with 0.9% sodium chloride or…

concentrated solution, diluted infusion solution, elastomeric infusion pump, fluorouracil, physicochemical stability

DOI: 10.5639/gabij.2024.1302.025

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI Journal) in 2018. Professor Othman Alshabanah, Saudi Arabia Dr Ahmet Bosnak, Turkey Professor Moses SS Chow, USA Professor Theodor Dingermann, Germany Professor Jaime Espin,…

Contents Editor’s Letter Medical journal publication during global stress Editorial Is the local tolerance of injectable biosimilars too underestimated? Commentary A white paper: US biosimilars market on pace with Europe Original Research Physicochemical stability of the bevacizumab biosimilar, ABP 215, after preparation and storage in intravenous bags Local policies on biosimilars: are they designed to…

Editor's Letter

Published on 16 December 2021

Fourth and final issue of GaBI Journal’s 10th volume

This issue of the GaBI Journal contains only a limited number of articles, but these include two scientific very data-rich articles and an interesting and important expose on the use and misuse of products to treat COVID-19 patients. All three articles have potentially major implications for the global struggle to deal with the current COVID-19…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1004.020

Sponsored Article

Published on 19 August 2022

Front-loading biosimilar development with analytical characterization

Abstract: An online roundtable discussion entitled ‘Front-loading biosimilar development with analytical characterization’ was hosted by BioPharmaSpec. The panellists discussed different regulatory approaches to the clinical trials needed for approval and how this can affect structural and functional characterization; the best way to ‘front-load’ characterization Submitted: 18 June 2022 Revised: 19 July 2022; Accepted: 20 July…

Author(s): Richard L Easton, BSC (Hons), DIC, PhD

analytics, biosimilars, functional testing, orthogonality, structural characterization

DOI: 10.5639/gabij.2022.1102.013