Articles

Guidelines

Published on 01 August 2012

ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities

Abstract:  The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scientific and technical...

Author(s): Keith McDonald, MSc, MRPharmS, Kowid Ho, PhD

biotechnological and chemical substances, drug substance quality, ICH Q11

DOI: 10.5639/gabij.2012.0103-4.025

35.669 views

Read more →

Readers' Comments

Published on 01 August 2012

A patient-centred paradigm for the biosimilars market This article provides important insights into the use and application of complex biologicals, particularly biosimilars, in health delivery systems. One aspect of care that has...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.024

5.274 views

Read more →

Abstracted Scientific Content

Published on 04 July 2012

Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care

Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care Oncologists have been urged to embrace biosimilar drug substitution to help control the spiralling costs of cancer care. However,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.022

7.768 views

Read more →

Regulatory

Published on 03 July 2012

Tighter EU rules on pharmacovigilance for biologicals

Received: 27 March 2012; Accepted: 22 May 2012 The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.015

12.065 views

Read more →

Conference Report

Published on 03 July 2012

The potential of generics policies: more room for exploitation–PPRI Conference Report

Author byline as per print journal: Sabine Vogler, PhD; Nina Zimmermann, MA Introduction: This Conference Report aims to provide an overview of key results, messages and conclusions of the Pharmaceutical Pricing and Reimbursement...

Author(s): Sabine Vogler, PhD, Nina Zimmermann, MA

competition, conference, generics policies, generics uptake, medicine prices, pricing, reimbursement

DOI: 10.5639/gabij.2012.0103-4.030

14.359 views

Read more →

Special Report

Published on 02 July 2012

The MEDICRIME Convention: criminalising the falsification of medicines and similar crimes

Abstract:  Trade in falsified/counterfeit medical products is a growing global criminal industry, posing a major threat to patients and healthcare systems. Falsified/Counterfeit medical products circulate via unregulated channels, especially the...

Author(s): Susanne Keitel, MD

Council of Europe, counterfeit medicines, criminalization, falsified medicines, international treaty, MEDICRIME Convention

DOI: 10.5639/gabij.2012.0103-4.029

27.972 views

Read more →

Perspective

Published on 02 July 2012

Biosimilars in oncology: current and future perspectives

Abstract: Cancer represents a significant, and growing, burden on healthcare systems. This is driven, at least in part, by escalating cancer drug budgets. Loss of patent protection on biopharmaceuticals enables...

Author(s): Matti Aapro, MD

biosimilars, cost burden, oncology

DOI: 10.5639/gabij.2013.0202.023

27.518 views

Read more →

Commentary

Published on 02 July 2012

Pharmacovigilance of biosimilars: challenges and possible solutions

Author byline as per print journal: Thijs J Giezen, PharmD, PhD; Sabine MJM Straus, MD, PhD Abstract:  Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small...

Author(s): Sabine MJM Straus, MD, PhD, Thijs J Giezen, PharmD, PhD, MSc

biologicals, biosimilars, immunogenicity, pharmacovigilance, traceability

DOI: 10.5639/gabij.2012.0103-4.033

16.781 views

Read more →

Review Article

Published on 02 July 2012

Reference pricing systems in Europe: characteristics and consequences

Author byline as per print journal: Pieter Dylst, PharmD; Professor Steven Simoens, MSc, PhD; Professor Arnold G Vulto, PharmD, PhD Introduction: A reference pricing system is a system that establishes a common reimbursement level...

Author(s): Pieter Dylst, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP, Steven Simoens, MSc, PhD

Europe, generic drugs, reference pricing system, reimbursement, review

DOI: 10.5639/gabij.2012.0103-4.028

89.659 views

Read more →

Original Research

Published on 02 July 2012

Saving money in the European healthcare systems with biosimilars

Introduction: The use of biotechnological manufactured drugs, or biologicals, has increased massively over the past few years. Used especially in the treatment of cancer and other severe diseases, biologicals incur high...

Author(s): Robert Haustein, Christoph de Millas, Ariane Höer, MD, Professor Bertram Häussler, MD

biologicals, biosimilars, cost savings, costs, epo, Europe, G-CSF, MAB

DOI: 10.5639/gabij.2012.0103-4.036

44.266 views

Read more →

Editor's Letter

Published on 29 June 2012

What to look forward to in GaBI Journal, 2012, issue 2

It is my pleasure to introduce the second edition of GaBI Journalwhich contains a number of interesting articles. Professors Benjamin and Kearns present a review of advances in paediatric drug...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0102.013

5.548 views

Read more →