Original Research

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
Page: 173-7

Author byline as per print journal: Aijing Zhang, PhD, Associate Professor Jung-Ying Tzeng, Professor Shein-Chung Chow, PhD Abstract: When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file… Read More »

Assessing biosimilarity using the method of generalized pivotal quantities

Published in: Volume 2 / Year 2013 / Issue 3
Author(s): ,
Page: 130-5

Author byline as per print journal: Shih-Ting Chiu, PhD, Chen Chen, MSc, Professor Shein-Chung Chow, PhD, Eric Chi, PhD Introduction: For generic approval of small-molecule (chemical) drug products, US Food… Read More »

Regional tenders on biosimilars in Italy: potentially competitive?

Published in: Volume 2 / Year 2013 / Issue 3
Author(s): , , , ,
Page: 123-9

Author byline as per print journal: Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Roberta Lo Muto, MSc, Silvy Duranti, MBA, Professor Livio Garattini Introduction: Health care in Italy is… Read More »

Efficient production of recombinant parathyroid hormone (rPTH) fragment 1-34 in the methylotrophic yeast Hansenula polymorpha

Published in: Volume 2 / Year 2013 / Issue 3
Author(s): ,
Page: 114-22

Author byline as per print journal: Frank Mueller, MSc, Manal Moussa, MSc, Maria El Ghazaly, MSc, Jan Rohde, PhD, Nicole Bartsch, MSc, Antje Parthier, PhD, Frank Kensy, Dr Ing Background:… Read More »

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