Original Research
Availability and procurement conditions of originator and generic medicines in hospitals – an exploratory study in five medium-sized European countries
Author(s): 1 Sabine Vogler, PhD, 2 Nina Zimmermann, MA, 3 Jan Mazag, PharmaDr
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
Author(s): Alexander E Finlayson, MD, MRCP, Brian Godman, BSc, PhD, Houmei Xi, B Eng, Rickard E Malmstrom, MD, PhD, Wenjie Zeng, BSc, PhD
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
Author(s): Abigail E Felix, BA, Anumeha Gupta, MD, Joshua P Cohen, PhD, Kim Riggs, MPH
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
Author(s): Frans Erdkamp, MD, PhD, Niels Boone, PharmD, Robert Janknegt, PharmD, PhD, Victor Zambon, MD
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)
Author(s): Alessandra Moglia, PhD, Corinne Emery, MSc, Jacques Rottembourg, MD
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
Author(s): 1 Richard O Dolinar, MD, Michael S Reilly, Esq
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
Author(s): 1 Rohit Kumar, MPharm, 2 Mohamed Azmi Ahmad Hassali, PhD, 3 Navneet Kaur, PhD, Muhamad Ali SK Abdul Kader, MD
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
Author(s): 1 Austin J Combest, PharmD, MBA, 2 Song Wang, PhD, 3 Brian T Healey, PharmD, MS, MBA, RAC, 4 Dirk J Reitsma, MD
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
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
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 »