Articles

Review Article

Published on 05 January 2021

Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers and regulators

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Teh Kee Siang, BSc (Pharm)(Hon); Associate Professor Chan Lai Wah, BSc (Pharm)(Hon), PhD Continuous manufacturing...

batch manufacturing, challenges, continuous manufacturing, harmonization, opportunity, regulatory

DOI: 10.5639/gabij.2021.1001.004

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Published on 02 December 2020

2020/4 GaBI Journal Table of Contents

Contents Editor’s Letter Medical journal publication during global stress Editorial Is the local tolerance of injectable biosimilars too underestimated? Commentary A white paper: US biosimilars market on pace with Europe...

1.837 views

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Editor's Letter

Published on 30 November 2020

Medical journal publication during global stress

This issue of the GaBI Journal is being published during one of the most turbulent periods in over a century. A deadly pandemic is raging, the global economy is stressed,...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0904.023

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Review Article

Published on 30 November 2020

An overview of the current status of follow-on biologicals in Iran

Author byline as per print journal: Farhang Rezaei, PharmD; Nassim Anjidani, PharmD Background: The advent of follow-on biologicals in Iran and biosimilars worldwide have provided various treatment options for several severe...

Author(s): Farhang Rezaei, PharmD, Nassim Anjidani, PharmD

biosimilars, Biotechnological therapeutics, follow-on biologics, Iran

DOI: 10.5639/gabij.2021.1002.010

6.670 views

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Original Research

Published on 30 November 2020

Biosimilars – status in July 2020 in 16 countries

Author byline as per print journal: Hye-Na Kang1, PhD; Robin Thorpe2, PhD; Ivana Knezevic1, PhD; Daehyun Baek3, PhD; Parichard Chirachanakul4; Hui Ming Chua5; Dina Dalili6, PhD; Freddie Foo7, MSc; Kai...

approval, biosimilar, survey, World Health Organization (WHO)

DOI: 10.5639/gabij.2021.1001.002

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Original Research

Published on 30 November 2020

Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation

Author byline as per print journal: Kelly Canham1, BSc Hons; Claire Newcomb2, MSc Introduction/Study Objectives: Etanercept is a tumour necrosis factor inhibitor indicated for the treatment of several inflammatory disorders....

autoinjector, biosimilar, etanercept, usability, YLB113

DOI: 10.5639/gabij.2021.1002.006

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Published on 27 October 2020

2020/3 GaBI Journal Table of Contents

Contents Editor’s Letter Latest features in GaBI Journal, 2020, Issue 3, 2020, Issue 3 Commentary Quality standards for biopharmaceuticals: the importance of good manufacturing practice Original Research Qualitative survey-based evaluation...

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Editorial

Published on 08 October 2020

Is the local tolerance of injectable biosimilars too underestimated?

Abstract: This editorial highlights the importance of carrying out comparative studies of patient tolerance to biosimilars and originator products. Minor side effects can affect their acceptability. Submitted: 23 September 2020;...

Author(s): Professor Alain Astier, PharmD, PhD

DOI: 10.5639/gabij.2020.0904.024

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Perspective

Published on 08 October 2020

Can local policies on biosimilars optimize the use of freed resources – experiences from Italy

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, MSc, PhD; Hye-Young Kwon, PhD1,6 Abstract: There is an increasing need to prescribe biosimilars...

Author(s): Brian Godman, BSc, PhD, Eleonora Allocati, BSc, MSc, Evelien Moorkens, BSc, MSc, Hye-Young Kwon, BPharm, MPH, PhD

biosimilars, demand-side measures, educational initiatives, Italy, savings

DOI: 10.5639/gabij.2020.0904.029

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Review Article

Published on 08 October 2020

Pharmaceutical Data Integrity: issues, challenges and proposed solutions for manufacturers and inspectors

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Vernon Tay1, BSc (Pharm) (Hons); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm)...

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Vernon Tay, BSc (Pharm) (Hons), Vimal Sachdeva, MSc

ALCOA-plus, audit trail, blockchain technology, computerized system, cooperation, data integrity

DOI: 10.5639/gabij.2020.0904.028

54.423 views

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Editor's Letter

Published on 22 September 2020

Latest features in GaBI Journal, 2020, Issue 3

The Commentary in this issue of the GaBI Journal by Dr Elwyn Griffiths discusses the need for more global harmonization of regulatory approaches to biological medicines. Dr Griffiths refers to...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0903.016

2.403 views

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