Potential changes to the FDA approach to biosimilars have a global impact

Published in: Volume 7 / Year 2018 / Issue 2
Page: 53-5

Abstract: The article of Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its guidance on biosimilar development. This article comments some of the proposals from… Read More »

EU Member States have tools to reduce costs of bestseller biologicals but can they use them?

Published in: Volume 7 / Year 2018 / Issue 1
Page: 5-7

Abstract: Major cost savings are achievable in pharmacotherapy in the European Union since biosimilars to most best-selling biological medicinal products have been licensed. Unfortunately, the window of opportunity may be… Read More »

Global policies on pharmacy-mediated substitution of biosimilars: a summary

Published in: Volume 6 / Year 2017 / Issue 4
Page: 155-6

Abstract: An extensive overview of policies related to pharmacy-mediated substitution of biosimilars across the world was carried out by Larkin et al. in 2017. The details of this are discussed… Read More »

Patent expiry and costs for anti­cancer medicines for clinical use

Published in: Volume 6 / Year 2017 / Issue 3
Author(s): , ,
Page: 105-6

Author byline as per print journal: Brian Godman, BSc, PhD; Claudia Wild, PhD; Alan Haycox, PhD Abstract: Venkatesan S et al. have researched patent rights and pricing for (non-)tyrosine kinase inhibitors.… Read More »

Strategies for pricing of pharmaceuticals and generics in developing countries

Published in: Volume 6 / Year 2017 / Issue 2
Author(s): ,
Page: 58-60

Abstract: Dr Brian Godman and Professor Mohamed Azmi Hassali review Rida et al. regarding pricing strategies for pharmaceuticals in developing countries. Submitted: 15 March 2017; Revised: 22 March 2017; Accepted:… Read More »

Biosimilars: achieving long-term savings and competitive markets

Published in: Volume 5 / Year 2016 / Issue 3
Author(s): , ,
Page: 103-4

Author byline as per print journal: Jorge Mestre-Ferrandiz, PhD; Adrian Towse, MA; Mikel Berdud, PhD Abstract: Payers need to think strategically in medium/long term to maximize benefits from biosimilars. Concerns… Read More »

Low-cost generic drug programs in the US: implications for payers and researchers

Published in: Volume 5 / Year 2016 / Issue 1
Page: 6-7

Abstract: Low-cost generic drug programs (LCGPs) provide affordable generics in the US. However, LCGPs have implications for managed care organizations and researchers relying on claims data. Submitted: 7 March 2016;… Read More »

Waiver of consent for retrospective chart review studies

Published in: Volume 5 / Year 2016 / Issue 1
Page: 8

Abstract: The importance of obtaining IRB/EC consent for waiver of consent before embarking on retrospective chart review studies was highlighted using the recent case of a manuscript submitted to GaBI… Read More »

Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Published in: Volume 4 / Year 2015 / Issue 4
Author(s): ,
Page: 159-60

Author byline as per print journal: Christoph Baumgärtel, MD, MSc; Brian Godman, BSc, PhD Abstract: Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as… Read More »

The challenges of nomenclature – INN, biosimilars and biological qualifiers

Published in: Volume 4 / Year 2015 / Issue 3
Page: 110-2

Abstract: A novel global and company specific biological qualifier, distinct from the International Nonproprietary Name (INN), is proposed by World Health Organization (WHO) for all biological active substances. Submitted: 14… Read More »

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