Articles

Meeting Report

Published on 02 March 2023

Non-medical switching of biologicals/biosimilars: Canada, Europe and the US – a webinar report

Author byline as per print journal: Michael S Reilly, Esq; Gail Attara; Ralph D McKibbin, MD, FACP, FACG, AGAF; Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP Introduction: Biosimilars are...

biologicals, biosimilars, forced-switching, interchangeable biosimilar, non-medical switching

DOI: 10.5639/gabij.2023.1201.006

5.999 views

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Opinion

Published on 05 January 2023

Biosimilars drug development: time for a paradigm shift?

Author byline as per print journal: Sandeep N Athalye, MBBS, MD; Shivani Mittra, MPharm, PhD; Ankitkumar M Ranpura, MD Abstract: The sky-rocketing cost of developing biosimilars is becoming a shared...

biosimilars, immunogenicity, interchangeability, switch studies

DOI: 10.5639/gabij.2023.1201.005

7.505 views

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Original Research

Published on 05 January 2023

Pharmacokinetics and relative bioavailability of sitagliptin hydrochloride and sitagliptin phosphate tablets formulations: a randomized, open-label, crossover study in healthy male volunteers

Author byline as per print journal: Chuei Wuei Leong1, PhD; Elton Sagim1, BBiomedSc, Kar Ming Yee1, BPharm; Muhammad Shalhadi Saharuddin1, BSc; Sharifah Radziah Syed Abd Rahim1, MSc; Khairil Sabri1, BSc;...

bioequivalence, new branded generics, sitagliptin hydrochloride, sitagliptin phosphate

DOI: 10.5639/gabij.2023.1201.004

7.237 views

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Original Research

Published on 24 November 2022

Pharmacokinetic bioequivalence of sitagliptin phosphate tablet formulations: a randomized, open-label, crossover study in healthy volunteers

Author byline as per print journal: Chuei Wuei Leong1, PhD; Elton Sagim1, BBiomedSc; Kar Ming Yee1, BPharm; Muhammad Shalhadi Saharuddin1, BSc; Nik Mohd Zulhakimi Nik Abdullah1, BSc; Noramirah Farhanah Saberi1,...

bioequivalence, new branded generics, pharmacokinetics, sitagliptin

DOI: 10.5639/gabij.2023.1201.003

3.012 views

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Editorial

Published on 05 January 2023

Response to the Opinion entitled ‘Biosimilars drug development: time for a paradigm shift?’

Abstract: The Opinion published in this issue of GaBI Journal titled ‘Biosimilars drug development: time for a paradigm shift?’ by Sandeep N Athalye, Shivani Mittra and Ankitkumar M Ranpur proposes...

Author(s): Robin Thorpe, PhD, FRCPath

biosimilars, clinical trials, guidance, immunogenicity, regulatory

DOI: 10.5639/gabij.2023.1201.002

4.989 views

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Editor's Letter

Published on 03 May 2023

Lagging acceptance of generic and biosimilar drug products; the rest of the story

The article in this issue of the GaBI Journal reminded me of The Rest of the Story radio programme originally hosted by Mr Paul Harvey that started each episode with,...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2023.1201.001

1.375 views

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Review Article

Published on 26 September 2022

Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study

Abstract: This article describes the European Pharmacopoeia (Ph. Eur.) exploratory study on infliximab as a test case for developing public standards for monoclonal antibodies. The design and outcome of the...

Author(s): Mihaela Buda, PhD

flexibility, infliximab, monographs, pharmacopoeia, public standards, reference preparations

DOI: 10.5639/gabij.2022.1103.017

4.389 views

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Original Research

Published on 08 September 2022

US prescribers’ attitudes and perceptions about biosimilars

Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Introduction: In the United States (US), a legal framework for approving biosimilars was...

biosimilars, interchangeability, substitution, switching, US

DOI: 10.5639/gabij.2022.1103.016

4.003 views

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Original Research

Published on 08 September 2022

Social trust and regional variation in the adoption of biosimilars in Italy and Germany

Introduction/Study Objectives: Adoption of biosimilars has fallen below projections, despite the vigorous implementation of economic incentives, thereby highlighting the importance of behavioural factors such as social trust. This paper analyses...

Author(s): Professor James C Robinson, PhD, MPH

biosimilars, drug prices, Germany, healthcare costs, Italy, social trust

DOI: 10.5639/gabij.2022.1103.015

4.772 views

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Editor's Letter

Published on 29 December 2022

The importance of trust

It seems as if the entire world is dealing with a lack of trust, even in many things that have enriched and sustained human development, including our neighbours, teachers, the...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1103.014

1.499 views

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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...

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

analytics, biosimilars, functional testing, orthogonality, structural characterization

DOI: 10.5639/gabij.2022.1102.013

1.628 views

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