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

7.187 views

Read more →

Original Research

Published on 07 July 2020

European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution

Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars...

Author(s): Madelaine A Feldman, MD, FACR, Michael S Reilly, Esq

biological medicines, biosimilar, EU, prescribers, substitution, survey

DOI: 10.5639/gabij.2020.0903.020

7.183 views

Read more →

Special Report

Published on 15 September 2015

Improving biosimilars uptake: experience gained in Madrid, Spain

Abstract: How to improve the uptake of biosimilars is a question that many countries are finding a challenge. Researchers from the Madrid Health Service investigate how initiatives in Spain have...

Author(s): GaBI Journal Editor

biological, biosimilar, Spain, uptake

DOI: 10.5639/gabij.2016.0502.021

7.174 views

Read more →

Meeting Report

Published on 14 June 2018

First ASEAN educational workshop on regulation and approval of biosimilars/similar biotherapeutic products 2017 – Report

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Elwyn Griffiths, PhD, DSc; Niklas Ekman, PhD Abstract: Biosimilar medicines are being increasingly developed and used worldwide. Many regulatory agencies across...

Author(s): Elwyn Griffiths, DSc, PhD, Niklas Ekman, PhD, Robin Thorpe, PhD, FRCPath

ASEAN, biologicals, biosimilars, education, regulatory, similar biotherapeutic product

DOI: 10.5639/gabij.2018.0703.025

7.124 views

Read more →

Editor's Letter

Published on 11 June 2014

What to look forward to in GaBI Journal, 2014, Issue 2

As mentioned previously, non-biological complex drugs (NBCDs) continue to raise important regulatory and practice issues. This issue of the GaBI Journal contains a number of manuscripts dealing with these products...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0302.015

7.122 views

Read more →

Letters to the Editor

Published on 26 October 2016

Is the EU ready for non-biological complex drug products?

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Gerrit Borchard, PharmD, PhD; Vinod P Shah, PhD; Beat Flühmann, PhD; Sesha Neervannan, PhD; Professor Stefan Mühlebach, PhD...

Author(s): Beat Flühmann, PhD, Jon SB de Vlieger, PhD, Professor Gerrit Borchard, PharmD, PhD, Professor Stefan Mühlebach, PhD, Sesha Neervannan, PhD, Vinod P Shah, PhD

complex drug products, EMA, generics, harmonization, non-biological complex drug (NBCD), therapeutic equivalence, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2016.0503.026

7.092 views

Read more →

Perspective

Published on 02 June 2015

Substantial savings with generics in Austria – and still room for more

Abstract: Austria has seen considerable savings with generics, due to its unique pricing system. Generic medicine penetration is, however, not as advanced as in other European countries. Additional savings could...

Author(s): Christoph Baumgärtel, MD, MSc

Austria, generics, price

DOI: 10.5639/gabij.2015.0403.030

7.019 views

Read more →

Commentary

Published on 29 June 2016

Biosimilars: achieving long-term savings and competitive markets

Author byline as per print journal: Jorge Mestre-Ferrandiz, PhD; Adrian Towse, MA; Mikel Berdud, PhD Abstract: Payers need to think strategically in medium/long term to maximize benefits from biosimilars. Concerns...

Author(s): Adrian Towse, MA, Jorge Mestre-Ferrandiz, PhD, Mikel Berdud, PhD

biosimilars, competition, incentives, real world outcomes, savings, value for money

DOI: 10.5639/gabij.2016.0503.027

6.969 views

Read more →

Abstracted Scientific Content

Published on 31 October 2016

Effect of naming on pharmacists’ perceptions and dispensing of biosimilars

Submitted: 21 November 2016; Revised: 22 November 2016; Accepted: 24 November 2016; Published online first: 30 November 2016 A study of pharmacists investigated their perceptions of biosimilar naming conventions and...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.048

6.927 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

6.906 views

Read more →

Abstracted Scientific Content

Published on 24 March 2014

Weighing up the cost of switching to biosimilars

It is far from clear whether off-patent biological medicines can offer the same cost savings as those offered by off-patent non-biological (chemically derived) medicines, write a group of Brussels-based health...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0302.025

6.883 views

Read more →