Commentary

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
Author(s):
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
Author(s):
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
Author(s):
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 »

The EU regulatory approach to generics and biosimilars is essentially similar

Published in: Volume 4 / Year 2015 / Issue 1
Author(s): , , ,
Page: 9-10

Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach… Read More »

Biosimilars versus ‘biobetters’—a regulator’s perspective

Published in: Volume 3 / Year 2014 / Issue 4
Author(s):
Page: 166-7

Abstract: The attractiveness of the biosimilar regulatory pathway is threatened by so-called biobetters. This paper provides definitions and an overview of recent developments. Submitted: 27 October 2014; Revised: 7 November… Read More »

Defining and characterizing non-biological complex drugs (NBCDs) – Is size enough? The case for liposomal doxorubicin generics (‘liposomal nanosimilars’) for injection

Published in: Volume 3 / Year 2014 / Issue 2
Author(s): ,
Page: 56-7

Abstract: ‘Non-binding recommendations’ from regulatory bodies are in place for evaluation and production of generic liposomal doxorubicin injection. However, how these nano-sized generics (‘nanosimilars’) should be characterized and evaluated, and… Read More »

The biosimilar name debate: what’s at stake for public health

Published in: Volume 3 / Year 2014 / Issue 1
Author(s):
Page: 10-2

Abstract: As the number of innovator biologics and biosimilars increases worldwide, a growing debate has focused on how these products should be named. The simple concept of a name can… Read More »

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