Original Research
Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients
Author(s): Maki Matsuhama, MSc, Ryosuke Kuribayashi, PhD
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
Author(s): Hannah Larkin, Judith Macdonald, Rebecca Lumsden, PhD
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
Author(s): Michael S Reilly, Esq, Stephen P Murby, FRSA
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
Author(s): 1 Sabine Vogler, PhD, Peter Schneider, MA
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 »
Naming and labelling of biologicals – a survey of US physicians’ perspectives
Author(s): Harry L Gewanter, MD, FAAP, FACR, Michael S Reilly, Esq
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 »
Naming and labelling of biologicals – the perspective of hospital and retail pharmacists
Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP
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MS, FASHP; Michael S Reilly, Esq Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance… Read More »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
Author(s): Eleftheria Karampli, MSc, Estathia Triga, MSc, John Kyriopoulos, PhD, Kostas Athanasakis, PhD, Vasiliki Tsiantou, MSc
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
Author(s): Harry L Gewanter, MD, FAAP, FACR, Michael S Reilly, Esq
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 »