Articles

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

5.752 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

2.174 views

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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

2.754 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

1.449 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

1.094 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

4.202 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

3.569 views

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Editor's Letter

Published on 10 January 2024

Latest features in GaBI Journal, 2023, Issue 3

The articles in this issue of the GaBI ­Journal highlight two important issues that must be considered when reading scientific publications. The first two articles illustrate the rapidly expanding influence...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2023.1203.012

1.171 views

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Review Article

Published on 18 October 2023

Trends in Saudi FDA drug approvals and GMP inspections: an observational study

Author byline as per print journal: Ali M Alhomaidan, PhD; Mohammed Abdulaziz Alageel, MSc; Turki Abdulaziz Alrafie, MSc; Hassan Mohammed Alqarni, MSc; Ibraheem Yahya Khbrani, MSc; Dalal J Alkhamis, MSc;...

Common Technical Documents, drug regulation, good manufacturing practice, Saudi FDA

DOI: 10.5639/gabij.2023.1203.013

8.030 views

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Editor's Letter

Published on 14 September 2023

Extrapolation requires reading between the lines

The articles in this second issue of 2023 include an Original Research (Internet questionnaire) of the ‘opinions’ of Canadian ophthalmologists, a Review Article describing a statistical method to assess the ‘drift’...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2023.1202.007

1.322 views

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Meeting Report

Published on 14 September 2023

Medicare drug price negotiations: impact on healthcare development and patient access to medicines

Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Esq; Steven J Potts, PhD, MBA; Andrew Spiegel, Esq Introduction: In the...

DOI: 10.5639/gabij.2023.1203.015

7.822 views

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Sponsored Article

Published on 14 September 2023

Biosimilar antibody drug conjugates: considerations of higher order structure and aggregation

Abstract: Undoubtedly the complexity of antibody drug conjugate (ADC) molecules where three components (monoclonal antibody, cytotoxic drug and appropriate linker) are involved poses a challenge for biosimilar development. As with...

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

antibody-drug conjugates, biosimilarity, characterization techniques, higher order structure, orthogonality, protein aggregation

DOI: 10.5639/gabij.2023.1203.018

2.941 views

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