Articles

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

4.423 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

2.931 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

1.878 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

2.351 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

6.323 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

2.463 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

3.011 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

1.576 views

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Research News

Published on 25 January 2024

Infliximab discontinuation in patients with originator retransition vs biosimilar continuation

Submitted: 4 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 2023 A study by Meijboom et al. aimed to compare the risk of and...

DOI: 10.5639/gabij.2023.1203.017

1.124 views

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Research News

Published on 11 January 2024

Switches between biosimilars and their reference products

Submitted: 22 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 2023 Biologics are the fastest-growing class of medications in the United States and account...

Author(s): Sarah Schrieber, PharmD

DOI: 10.5639/gabij.2023.1203.016

4.295 views

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Original Research

Published on 11 January 2024

Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software

Author byline as per print journal: Dhananjay Panigrahi1, MPharm; Aditya Murthy2, MPharm, PhD; Shubham Jamdade2, MPharm; Manoj Gundeti2, MPharm; Nagarjun Rangaraj1, MPharm, PhD; Anup Avijit Choudhury1, MPharm; Tausif Ahmed2, MPharm,...

etoricoxib, GastroPlus®, modelling and simulation, PBBM, spray granulation, virtual bioequivalence

DOI: 10.5639/gabij.2024.1301.003

3.765 views

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