Original Research

Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients

Published in: Volume 7 / Year 2018 / Issue 1
Author(s): ,
Page: 8-13

Introduction/Study objectives: A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). API manufacturers generally register API information as a Drug… Read More »

Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution policies

Published in: Volume 6 / Year 2017 / Issue 4
Author(s): , ,
Page: 157-64

Introduction/Study objectives: Between March and May 2017, Pfizer conducted an internal global survey of 82 countries examining biosimilar pharmacy-mediated substitution to understand and benchmark the global policy landscape. Methods: Pfizer… Read More »

A survey of Australian prescribers’ views on the naming and substitution of biologicals

Published in: Volume 6 / Year 2017 / Issue 3
Author(s): ,
Page: 107-13

Author byline as per print journal: Stephen P Murby, FRSA; Michael S Reilly, Esq Introduction: As the number of biosimilar approvals in Australia increases, it is important to build on the… Read More »

Do pricing and usage-enhancing policies differ between biosimilars and generics? Findings from an international survey

Published in: Volume 6 / Year 2017 / Issue 2
Author(s): ,
Page: 79-88

Introduction/Study objective: This paper aims to survey the policies implemented by European countries for pricing and promoting the use of biosimilar medicines and to explore similarities and differences with policies… Read More »

What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

Published in: Volume 6 / Year 2017 / Issue 2
Author(s): , ,
Page: 61-78

Author byline as per print journal: Jean-Baptiste Reiland, MSc; Barbara Freischem; Alexander Roediger, MA Introduction/Study objective Biosimilar policies with a focus on uptake have received a lot of attention at national… Read More »

Naming and labelling of biologicals – a survey of US physicians’ perspectives

Published in: Volume 6 / Year 2017 / Issue 1
Author(s): ,
Page: 7-12

Introduction: The US Food and Drug Association (FDA) released its requirements for the non-proprietary naming of biological products in January 2017. Before the FDA’s release, the Alliance for Safe Biologic… Read More »

Assessment of active pharmaceutical ingredients in drug registration procedures in Pakistan: implications for the future

Published in: Volume 5 / Year 2016 / Issue 4
Author(s): , , , , ,
Page: 156-63

Author byline as per print journal: Babar Khan, BPharm, MPH, PhD; Brian Godman, BSc, PhD; Ayesha Babar, BPharm, MPhil; Shahzad Hussain, BPharm, MPhil; Sidra Mahmood, PharmD, MSc; Tahir Aqeel, BPharm, MPhil… Read More »

Naming and labelling of biologicals – the perspective of hospital and retail pharmacists

Published in: Volume 5 / Year 2016 / Issue 4
Author(s): ,
Page: 151-5

Author byline as per print journal: Professor Philip J Schneider, MS, FASHP; Michael S Reilly, Esq Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance… Read More »

Views of physicians and patients with chronic conditions on generic medicines in Greece after the introduction of measures to promote their consumption: findings from a qualitative study

Published in: Volume 5 / Year 2016 / Issue 1
Author(s): , , , ,
Page: 9-20

Author byline as per print journal: Eleftheria Karampli, MSc; Estathia Triga, MSc; Vasiliki Tsiantou, MSc; Kostas Athanasakis, PhD; John Kyriopoulos, PhD Introduction/Study objectives: Generic medicines uptake is widely acknowledged as… Read More »

Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico

Published in: Volume 4 / Year 2015 / Issue 4
Author(s): ,
Page: 161-6

Author byline as per print journal: Michael S Reilly, Esq; Harry L Gewanter, MD, FAAP, FACR Introduction: World Health Organization (WHO) recommendations for the regulation of biosimilars form the basis of… Read More »

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