Articles

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

53.736 views

Read more →

Original Research

Published on 03 August 2020

Local policies on biosimilars: are they designed to optimize use of liberated resources?

Author byline as per print journal: Arianna Bertolani, PhD; Claudio Jommi, MS Study Objectives: Different policies have been implemented to enhance uptake of biosimilars. Regarding policies focussing on the demand-side,...

Author(s): Arianna Bertolani, PhD, Claudio Jommi, MS

biosimilars, Italian national health service, local policies

DOI: 10.5639/gabij.2020.0904.027

10.739 views

Read more →

Original Research

Published on 03 August 2020

Physicochemical stability of the bevacizumab biosimilar, ABP 215, after preparation and storage in intravenous bags

Author byline as per print journal: Jolita Seckute1, PhD; Ingrid Castellanos2, PhD; Steven Bane1, PhD Study Objectives: To evaluate extended in-use stability of bevacizumab biosimilar, ABP 215, after dilution into...

ABP 215, administration, bevacizumab, biosimilar, infusion, stability

DOI: 10.5639/gabij.2020.0904.026

16.082 views

Read more →

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

6.005 views

Read more →

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

2.138 views

Read more →

Meeting Report

Published on 25 March 2020

3rd Colombian educational workshop on regulatory assessment of biosimilars 2019 – Report

Author byline as per print journal: Professor John-Joseph Borg, PhD; Yolanda Elias Gramajo, MD; Professor Andrea Laslop, MD; Robin Thorpe, PhD, FRCPath; Jian Wang, MD, PhD Introduction: Biosimilars have the...

Author(s): Jian Wang, MD, PhD, Professor Andrea Laslop, MD, Professor John-Joseph Borg, Robin Thorpe, PhD, FRCPath, Yolanda Elias Gramajo, MD

biologicals, biosimilars, Colombia, INVIMA

DOI: 10.5639/gabij.2020.0903.022

8.565 views

Read more →

Regulatory

Published on 26 May 2020

Pelmeg®, a biosimilar pegfilgrastim developed in the context of evolving regulatory guidelines

Author byline as per print journal: Karsten Roth, PhD; Hendrik Wessels, PhD; Josef Höfler, PhD; Ulrike Scholz, PhD; Dirk Lehnick, PhD Abstract: Pelmeg® is a biosimilar pegfilgrastim, which obtained European...

Author(s): Dirk Lehnick, PhD, Hendrik Wessels, PhD, Josef Höfler, PhD, Karsten Roth, PhD, Ulrike Scholz, PhD

biosimilar, filgrastim, Neulasta®, pegfilgrastim, Pelmeg®, targeted development

DOI: 10.5639/gabij.2020.0903.021

18.322 views

Read more →

Original Research

Published on 03 August 2020

Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods

Author byline as per print journal: Rieke Alten1, MD, PhD; Herbert Kellner2, MD; Malcolm Boyce3, MD; Takuma Yonemura4, MD; Takahiro Ito5, MSc; Mark C Genovese6, MD Introduction/Study objectives: FKB327 is...

adalimumab, anti-TNF therapy, biosimilars, clinical trials, injection-site pain, rheumatoid arthritis

DOI: 10.5639/gabij.2020.0903.019

10.351 views

Read more →

Original Research

Published on 07 July 2020

Qualitative survey-based evaluation of operability and convenience for the etanercept biosimilar YLB113 in a unique injection pen in patients with rheumatoid arthritis

Author byline as per print journal: Toshihiko Hibino1, MD; Tomohiko Yoshida2, MD, PhD; Akira Sagawa3, MD, PhD; Ikuko Masuda4, MD, PhD; Takaaki Fukuda5, MD Introduction/Study objective: Needle fear is common...

etanercept, injection pen, needle fear, rheumatoid arthritis, usability, YLB113

DOI: 10.5639/gabij.2020.0903.018

23.984 views

Read more →

Commentary

Published on 07 July 2020

Quality standards for biopharmaceuticals: the importance of good manufacturing practice

Abstract: Regulatory standards for recombinant DNA (rDNA)-derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their...

Author(s): Elwyn Griffiths, DSc, PhD

ASEAN, biologicals, biosimilars, GMP, regulatory harmonization

DOI: 10.5639/gabij.2020.0903.017

6.365 views

Read more →

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

2.400 views

Read more →