Articles

Abstracted Scientific Content

Published on 22 June 2021

An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms

Submitted: 14 May 2021; Revised: 14 May 2021; Accepted: 3 June 2021; Published online first: 10 June 2021 Medicines regulatory authorities aim to address rising healthcare costs and promote access...

Author(s): Alfredo García Arieta, PhD, Clare Rodrigues

DOI: 10.5639/gabij.2021.1003.019

3.587 views

Read more →

Review Article

Published on 22 June 2021

Microbiological, scientific and regulatory perspectives of hand sanitizers

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Tan Ying Ting, BSc Pharm (Hons); Associate Professor Chan Lai Wah, BSc Pharm (Hons), PhD...

effectiveness, hand sanitizers, myths, regulatory framework, safety, standards

DOI: 10.5639/gabij.2021.1003.017

8.702 views

Read more →

Published on 22 June 2021

2021/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2021, Issue 2 Original Research Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation Biosimilars in Saudi...

1.624 views

Read more →

Abstracted Scientific Content

Published on 21 May 2021

Repurposing non-oncology drugs for cancer treatment

Submitted: 15 March 2021; Revised: 17 March 2021; Accepted: 18 March 2021; Published online first: 24 March 2021 Cancer is one of the leading causes of mortality in the world...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2021.1002.011

2.559 views

Read more →

Editor's Letter

Published on 20 May 2021

What to look forward to in GaBI Journal, 2021, Issue 2

The current pandemic has greatly amplified the already existing disparities in access to health care. Many countries are facing a lack of access to or funding to pay for the...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1002.005

3.002 views

Read more →

Thank you to reviewers

Published on 09 March 2021

Thank you to reviewers 2020

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...

2.607 views

Read more →

Published on 09 March 2021

2021/1 GaBI Journal Table of Contents

Contents Editor’s Letter First 2021 GaBI Journal issue highlights Original Research Biosimilars – status in July 2020 in 16 countries An assessment of trends in the Iranian pharmaceutical market following...

1.756 views

Read more →

Editor's Letter

Published on 23 February 2021

First 2021 GaBI Journal issue highlights

The articles in this first issue contain a large volume of useful information on the global development, approval, manufacturing, marketing, and uptake of biosimilars. The first Original Research by Dr...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1001.001

2.674 views

Read more →

Review Article

Published on 23 February 2021

The EU regulatory network and emerging trends – a review of quality, safety and clinical development programmes

Author byline as per print journal: Marta Zuccarelli1, PharmD; Benjamin Micallef1, PharmD; Mark Cilia1, PharmD; Anthony Serracino-Inglott1,2, PharmD; John-Joseph Borg1,3, PhD Introduction/Study Objectives: The development of biosimilars is challenging due...

biosimilars, clinical development programmes, EMA, EPARs, regulatory, safety

DOI: 10.5639/gabij.2021.1002.009

6.973 views

Read more →

Original Research

Published on 23 February 2021

Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study

Author byline as per print journal: Pieter J Glerum1,2, MSc; Mert Hayta1,3, PharmD, MSc; David M Burger4, PharmD, PhD; Cees Neef5, PharmD, PhD; Marcel L Bouvy3, PharmD, PhD; Marc Maliepaard1,6,...

Brand-name drugs, drug switching, generic drugs, generics substitution, interchangeability, pharmacy practice

DOI: 10.5639/gabij.2021.1003.014

10.701 views

Read more →

Original Research

Published on 23 February 2021

Biosimilars in Saudi Arabia: a single-centre, open-label case series examining infliximab switching

Author byline as per print journal: Mansour Somaily1, MD; Hana Alahmari1, MD; Wejdan Abbag2; Shahenda Yousif4, MD; Nawar Tayfour4, MD; Nouf Almushayt2; Saleh Alhusayni3, MD; Saeed Almajadiah4, MD Background: A...

Ankylosing spondylitis, Bechet's disease, CT-P13, infliximab, rheumatoid arthritis

DOI: 10.5639/gabij.2021.1002.007

6.655 views

Read more →

Original Research

Published on 03 February 2021

Variation in the prices of oncology medicines across Europe and the implications for the future

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Steven Simoens4, MSc, PhD; Amanj Kurdi1,5, BSc, PhD; Gisbert Selke6; John Yfantopoulos7, PhD; Andrew Hill8, PhD; Jolanta Gulbinovič9, MD, PhD;...

cancer, cross-national, Europe, generics, health policies, pricing

DOI: 10.5639/gabij.2021.1002.008

7.472 views

Read more →