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 »

Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines

Published in: Volume 4 / Year 2015 / Issue 2
Author(s): , ,
Page: 58-63

Abstract: The backlog in medicines registration in South Africa is a result of the implementation of pro-generics policies without strengthening the regulator to handle the substantial increase in registration applications… Read More »

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