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Commentary

Published on 16 December 2014

The EU regulatory approach to generics and biosimilars is essentially similar

Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach...

Author(s): Barbara J van Zwieten-Boot, Marcel Hoefnagel, Peter MJM Jongen, R Martijn van der Plas

active substance, biosimilar, EMA, Europe, guidelines, regulatory

DOI: 10.5639/gabij.2015.0401.004

11.310 views

Editorial

Published on 15 December 2014

Availability and procurement of generics in hospitals among medium-sized European countries

Abstract: Dr Brian Godman reviews the paper by Vogler and co-authors on the procurement of generics or originators among European hospitals once multiple sources become available. Submitted: 28 November 2014;...

Author(s): Brian Godman, BSc, PhD

Europe, generics, hospitals, procurement

DOI: 10.5639/gabij.2014.0304.037

9.263 views

Interview

Published on 12 December 2014

Amgen’s move into the biosimilars market

Abstract: Biotech giant Amgen now has a biosimilars programme that includes nine different molecules. A representative from Amgen has spoken to GaBI about the company’s venture into biosimilars. Topics included...

Author(s): GaBI Journal Editor

biosimilar, naming, uptake

DOI: 10.5639/gabij.2014.0304.048

6.629 views

Opinion

Published on 01 December 2014

Is Australia positioned to take advantage of biosimilars?

Abstract: Australia currently has a small generic and biosimilar medicine industry despite having a good track record in biomedical research and a sound reputation in producing high quality but small...

Author(s): David Lim, DPH

Australia, biosimilars, confidential information, patent, regulation, remuneration

DOI: 10.5639/gabij.2014.0304.042

9.867 views

Pharma News

Published on 01 December 2014

Reducing the European healthcare budget with generics and biosimilars

The world market for medicinal products is expected to reach US$1 trillion in 2014. Global spending on medicines is expected to grow to nearly US$1.2 trillion by 2017 [1]. As...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.046

7.550 views

Commentary

Published on 28 November 2014

Biosimilars versus ‘biobetters’—a regulator’s perspective

Abstract: The attractiveness of the biosimilar regulatory pathway is threatened by so-called biobetters. This paper provides definitions and an overview of recent developments. Submitted: 27 October 2014; Revised: 7 November...

Author(s): René Anour, DVM

biobetter, biosimilar, competition, interchangeability, regulatory pathways

DOI: 10.5639/gabij.2014.0304.039

124.332 views

Published on 04 November 2014

2014/3 GaBI Journal Table of Contents

Contents Editor’s Letter Latest features in GaBI Journal, 2014, Issue 3 Editorial Regional regulatory processes for the approval of biosimilars; differences and similarities Original Research Barriers to market uptake of...

3.358 views