Original Research

What pricing and reimbursement policies to use for off-patent biologicals? – Results from the EBE 2014 biological medicines policy survey

Published in: Volume 4 / Year 2015 / Issue 1
Page: 17-24

Objective: One of the questions that the advent of biosimilars raises is whether the different nature of biological medicines would also imply the need for a different policy approach by… Read More »

Availability and procurement conditions of originator and generic medicines in hospitals – an exploratory study in five medium-sized European countries

Published in: Volume 3 / Year 2014 / Issue 4
Author(s): , ,
Page: 168-79

Aim: To explore whether medicines used in hospitals in European countries are supplied as originators or generic medicines, and to investigate the procurement conditions, including the extent of discounts at… Read More »

Ongoing initiatives to improve prescribing efficiency in China; statins as a case history

Published in: Volume 3 / Year 2014 / Issue 3
Author(s): , , , ,
Page: 122-32

Author byline as per print journal: Wenjie Zeng, BSc, PhD; Houmei Xi, B Eng; Brian Godman, BSc, PhD; Alexander E Finlayson, MD, MRCP;  Rickard E Malmstrom, MD, PhD Introduction: Pharmaceutical expenditure… Read More »

Barriers to market uptake of biosimilars in the US

Published in: Volume 3 / Year 2014 / Issue 3
Author(s): , , ,
Page: 108-15

Author byline as per print journal: Joshua P Cohen, PhD; Abigail E Felix, BA; Kim Riggs, MPH; Anumeha Gupta, MD Background: In the US, a new approval pathway for biosimilars has been established… Read More »

GnRH agonists and antagonists in prostate cancer

Published in: Volume 3 / Year 2014 / Issue 3
Author(s): , , ,
Page: 133-42

Author byline as per print journal: Robert Janknegt, PharmD, PhD, Niels Boone, PharmD, Frans Erdkamp, MD, PhD, Victor Zambon, MD Abstract: This manuscript describes the System of Objectified Judgement Analysis… Read More »

Retrospective chart review: disrupted anaemia control in haemodialysis patients following the switch to an iron sucrose similar (ISS) after long-term treatment with the originator iron sucrose (IS)

Published in: Volume 3 / Year 2014 / Issue 3
Author(s): , ,
Page: 116-21

Author byline as per print journal: Professor Jacques Rottembourg, MD; Corinne Emery, MSc; Alessandra Moglia, PhD Study objective: To describe and compare the haematological parameters and the anaemia medication use in… Read More »

Biosimilars naming, label transparency and authority of choice – survey findings among European physicians

Published in: Volume 3 / Year 2014 / Issue 2
Author(s): ,
Page: 58-62

Introduction: A survey of the views of European physicians on familiarity of biosimilar medicines has demonstrated the need for distinguishable non-proprietary names to be given to all biologicals. Methods: The… Read More »

Perceptions of physicians from private medical centres in Malaysia about generic medicine usage: a qualitative study

Published in: Volume 3 / Year 2014 / Issue 2
Author(s): , , ,
Page: 63-70

Introduction: The healthcare sector is one of the most rapidly expanding and dynamic industries in the world. Pharmaceutical expenditure is now growing faster than other components of healthcare overheads. Globally,… Read More »

Alternative statistical strategies for biosimilar drug development

Published in: Volume 3 / Year 2014 / Issue 1
Author(s): , , ,
Page: 13-20

Introduction: Many regulatory authorities have published requirements for the approval of biosimilar medicinal products. However, there is no guidance on which quantitative standards should be used to define how similar… Read More »

Establishment of reference standards in biosimilar studies

Published in: Volume 2 / Year 2013 / Issue 4
Author(s): , ,
Page: 173-7

Abstract: When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative… Read More »

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