Original Research

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

Introduction: There are concerns over the quality of generic medicines in Pakistan. This is due to perceived non-compliance with good manufacturing practice (GMP), whereby the quality of the raw materials… 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

Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance on the naming of biosimilar medicines. The Alliance for Safe Biologic Medicines (ASBM) has asked… 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

Introduction: World Health Organization (WHO) recommendations for the regulation of biosimilars form the basis of guidelines used across most of Latin America. However, the pace at which the region moves… Read More »

Product naming, pricing, and market uptake of biosimilars

Published in: Volume 4 / Year 2015 / Issue 2
Author(s): , , , , ,
Page: 64-71

Abstract: With a number of patents on biological medicines soon to expire in the US, multiple stakeholders – from policymakers to manufacturers to payers – have been debating the structure… Read More »

Pharmaceutical pricing in Croatia: a comparison of ordinances in 2013 versus 2009 and their potential savings to provide future guidance

Published in: Volume 4 / Year 2015 / Issue 2
Author(s): , , , , , ,
Page: 79-89

Introduction: Croatia has introduced a number of reforms to contain pharmaceutical expenditure whilst increasing access to new medicines. These include new regulations and new ordinances in 2013 including the pricing… Read More »

Differences in pharmacokinetic behaviour of branded enoxaparin and a US generic version in a non-human primate model

Published in: Volume 4 / Year 2015 / Issue 2
Author(s): , , , , , , ,
Page: 72-8

Introduction: Low molecular weight heparins (LMWHs) are composed of a heterogeneous mixture of oligosaccharides that express a spectrum of biological activities. Studies conducted in primates (Macaca mulatta) comparing branded and… Read More »

Payer and physician evidence and discount requirements for biosimilars in three Latin American countries

Published in: Volume 4 / Year 2015 / Issue 1
Author(s): , , , ,
Page: 11-6

Study objectives: In Latin America, many governments have attempted to address biosimilar safety and efficacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores… Read More »

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 »

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