Articles

Review Article

Published on 04 May 2023

Statistical tests for detecting reference product change in biosimilar studies

Author byline as per print journal: Jiayin Zheng1, PhD; Peijin Wang`2, MS; Yixin Wang3, PhD; Shein-Chung Chow2, PhD Abstract: For the biosimilarity assessment between a test product and a reference...

DOI: 10.5639/gabij.2023.1202.009

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Original Research

Published on 04 May 2023

Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars

Author byline as per print journal: Michael S Reilly, Esq; Jane Barratt, PhD Introduction: The first biosimilar entered the Canadian market in 2009 and the first ophthalmic biosimilar was approved...

biologicals, biosimilars, Canada, ophthalmology

DOI: 10.5639/gabij.2023.1202.008

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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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Special Report

Published on 02 March 2023

Follow-on biologicals/biosimilars approved in Brazil: May 2023 update

Abstract: Brazilian requirements for approval of biosimilars are aligned with a strict regulatory process and ensure the same high standards of quality, safety and efficacy as for originator biologicals. Submitted:...

Author(s): Sílvia Helena Cestari de Oliveira, MSc

biologicals, biosimilars, Brazil

DOI: 10.5639/gabij.2023.1202.011

6.510 views

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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

6.000 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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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

7.508 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

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Published on 03 January 2023

2022/3 GaBI Journal Table of Contents

Contents Editor’s Letter The importance of trust Original Research Social trust and regional variation in the adoption of biosimilars in Italy and Germany US prescribers’ attitudes and perceptions about biosimilars Review...

1.108 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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Published on 29 November 2022

2022/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2022, Issue 2 Commentary Substitution and interchangeability: time for a conversation? Original Research On statistical evaluation for interchangeability of...

1.016 views

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Thank you to reviewers

Published on 29 November 2022

Thank you to reviewers 2021

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI...

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