Editor's Letter

Published on 10 September 2024

What to look forward to in GaBI Journal, 2024, Issue 2

Issue 2 of Volume 13 of GaBI ­Journal starts with a Review Article by Paul et al., titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries’. The review focuses on treatment of non-communicable diseases as these disproportionately affect people living in low- and middle-income countries compared to high-income countries. Challenges…

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1302.007

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

Abstract:US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the legal designation was first created in 2010. Based on experience, FDA now acknowledges that clinical switching studies are not generally needed for the interchangeability designation as quality, safety and efficacy are established by biosimilarity already. Approval pathways for biosimilars and interchangeable…

Author(s): Gillian R Woollett, MA, DPhil, Joseph P Park, PhD

biosimilars, BPCIA, interchangeability, market exclusivity, quality, switching

DOI: 10.5639/gabij.2024.1303.035

Editor's Letter

Published on 11 July 2024

First 2024 GaBI Journal issue highlights

It was with great pleasure that I assumed the role of Editor-in-Chief (EiC) of GaBI Journal in January of this year. Taking over the helm from Professor Philip D Walson is a considerable challenge; Phil’s excellent, thorough example will be very difficult to follow. My experience is restricted largely to biosimilars with which I have…

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1301.001

Abstract: Monoclonal antibodies and cell therapies play an increasingly significant role in anticancer therapy, but small molecules remain an essential part of combination chemotherapy. Despite the publication of many studies on the extended stability of small molecule preparations, not all licensed medicinal products and stability-determining factors are covered. Submitted: 26 April 2024; Revised: 9 May…

Author(s): Irene Krämer, PhD, Judith Thiesen, PhD

anticancer drugs, cytotoxic, in-use stability, parenteral administration

DOI: 10.5639/gabij.2024.1302.010

Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Abstract: The US biosimilar programme has been highly successful with 53 biosimilars approved by the US Food and Drug Administration (FDA) for 17 reference products. As in most advanced nations of Europe, all FDA-approved biosimilars may be substituted…

biosimilarity, interchangeability, misinformation, regulation, uptake

DOI: 10.5639/gabij.2024.1302.009

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

Abstract: The US Food and Drug Administration (FDA) proposed eliminating the distinction between biosimilars and interchangeable biosimilars with the stated aim of aligning with European policy and enhance biosimilar uptake. However, this move is misguided as it would result in widespread generic-style automatic substitution at the pharmacy level; which is rare in Europe. Physician confidence…

Author(s): Michael S Reilly, Esq

formulary, interchangeable biosimilar, market uptake, pharmacy benefit managers

DOI: 10.5639/gabij.2024.1301.006

Author byline as per print journal: Pritha Paul1, PhD; Rahul Kapur2*, MBBS, PhD; Shivani Mittra3, MPharm, PhD; Nimish Shah4, JD, MBA; Gopal K Rao1, MSc; Matthew E Erick4, BS, RPh; Susheel Umesh1, BPharm, MBA; Sandeep N Athalye2, MBBS, MD Abstract:Non-communicable diseases (NCDs) disproportionately affect people living in low- and middle-income countries (LMICs) compared to high-income…

affordability, biosimilars, low- and middle-income countries (LMICs), market access, non-communicable diseases, regulatory framework

DOI: 10.5639/gabij.2024.1302.008

Abstract: In principle, biosimilars could mitigate the problem of the rising cost of biological medicines. However, the current stringent and non-harmonized regulatory practices hinder competition and contribute to the high price level of biosimilars. The quality, safety, and efficacy of biosimilars developed, according to the current guidelines of ‘stringent’ regulatory agencies have proven to be…

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

biosimilars, competition, controlled efficacy studies, harmonization

DOI: 10.5639/gabij.2024.1301.004

Table Contents

Published on 15 April 2024

2024/1 GaBI Journal Table of Contents

Editor’s Letter First 2024 GaBI Journal issue highlights Original Research Budget impact analysis of a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in Chile Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software Perspective Comparative efficacy…

Original Research

Published on 21 March 2024

Budget impact analysis of a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in Chile

Author byline as per print journal: Tomás Abbot1, MSc; Nicolás Armijo1, MSc; Robin Piron2, PhD; Manuel Espinoza1,3, PhD Introduction: In Chile, access disparities and budget constraints affect the treatment of non-Hodgkin lymphoma patients, even though therapies like rituximab are covered by the Regime of Explicit Health Guarantees. Biosimilars like Rixathon® off er a compelling alternative…

biosimilars, budget impact analysis, Chile, health system perspective, non-Hodgkin lymphoma, rituximab

DOI: 10.5639/gabij.2024.1301.002