Articles

Perspective

Published on 23 August 2024

The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies

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...

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

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

DOI: 10.5639/gabij.2024.1303.036

1.709 views

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Perspective

Published on 21 August 2024

US interchangeability designation: are we ready to cut the Gordian knot?

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...

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

2.628 views

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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...

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1301.001

1.056 views

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Special Report

Published on 11 July 2024

Extended stability data on small molecule anticancer medicinal products – anything new? any additional information necessary?

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...

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

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

DOI: 10.5639/gabij.2024.1302.010

4.426 views

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Perspective

Published on 11 July 2024

Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health

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...

biosimilarity, interchangeability, misinformation, regulation, uptake

DOI: 10.5639/gabij.2024.1302.009

2.968 views

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Review Article

Published on 30 July 2024

Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials

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...

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

1.949 views

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Opinion

Published on 10 May 2024

Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars

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....

Author(s): Michael S Reilly, Esq

formulary, interchangeable biosimilar, market uptake, pharmacy benefit managers

DOI: 10.5639/gabij.2024.1301.006

2.364 views

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Review Article

Published on 07 May 2024

Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries

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;...

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

DOI: 10.5639/gabij.2024.1302.008

6.356 views

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Perspective

Published on 19 April 2024

Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort

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...

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

biosimilars, competition, controlled efficacy studies, harmonization

DOI: 10.5639/gabij.2024.1301.004

2.483 views

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GJ 2024-1 Cover Web V24H08 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...

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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...

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

DOI: 10.5639/gabij.2024.1301.002

3.019 views

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Perspective

Published on 06 March 2024

Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements

Author byline as per print journal: Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay Singhvi, BSc (Hon), MBBS, MBA Introduction: Healthcare providers often lack familiarity...

biosimilar, education, oncology, regulatory

DOI: 10.5639/gabij.2024.1301.005

1.582 views

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