Commentary
Biosimilars: achieving long-term savings and competitive markets
Author(s): Adrian Towse, MA, Jorge Mestre-Ferrandiz, PhD, Mikel Berdud, PhD
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
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 »
Bioequivalence of narrow therapeutic index drugs and immunosuppressives
Author(s): Brian Godman, BSc, PhD, Christoph Baumgärtel, MD, MSc
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
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
Author(s): 1 Henry MJ Leng, PhD, 2 David Sanders, MRCP, Allyson M Pollock, MBChB, FFPH, MRCP (Ed), MRCGP
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 »
Biosimilars versus ‘biobetters’—a regulator’s perspective
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
Author(s): Professor S Moein Moghimi, PhD, Z Shadi Farhangrazi, PhD
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 »
Strategies for pricing of pharmaceuticals and generics in developing countries
Author(s): Brian Godman, BSc, PhD, Professor Mohamed Azmi Hassali, PhD
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 »