Articles

Review Article

Published on 14 September 2023

The incorporation of the Halal Management System (HMS) by the pharmaceutical industry

Author byline as per print journal: Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri2,3; Noor Fadzilah Zulkifli1; Mohd Mahyeddin Mohd Salleh3; Nazariyah Yahaya4; Khairun Nain Nor Aripin1; Shahirah Nadiah Shaharuddin5;...

halal assurance, halal pharmaceuticals, oral dosage, supply chain

DOI: 10.5639/gabij.2023.1203.014

7.414 views

Read more →

Perspective

Published on 08 August 2023

Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?

Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ankit Ranpura1, MD; Kuldeep Kumar1, PhD; Elena Wolff-Holz2, MD Abstract: Ethnic...

biosimilar development, ethnic sensitivity assessments, global access, monoclonal antibodies, multi-regional clinical trials, regulatory reforms

DOI: 10.5639/gabij.2023.1202.010

10.515 views

Read more →

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

4.874 views

Read more →

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

5.660 views

Read more →

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

1.392 views

Read more →

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

6.624 views

Read more →

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

6.133 views

Read more →

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

5.026 views

Read more →

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

7.609 views

Read more →

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

7.559 views

Read more →

Thank you to reviewers

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...

1.120 views

Read more →

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

1.503 views

Read more →