Search results for biosimilars

Promoting access to biosimilars: a public−private partnership model for biosimilar development in underserved populations

Author byline as per print journal: Timothy Ken Mackey1,2, MAS; Professor Bryan A Liang1,3,4, MD, JD, PhD Abstract:  Biologicals represent the future of pharmaceutical treatments and innovation. Yet, emerging and developing markets lack access to these often essential medicines. Biosimilar development represents a potential solution to this problem, by offering lower cost and improved access, but […]

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Nomenclature for biosimilars; a continuing thorny issue

Abstract: Nomenclature for biosimilars is a controversial issue. In this issue of GaBI Journal, a paper by Sarshad et al. considers the US FDA’s published system for this and concludes that it will be a positive solution to a global issue. But this may be a premature judgement. Submitted: 1 January 2019; Revised: 3 January […]

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Generics substitution in primary care: summary of the Dutch community pharmacies guidelines

Abstract:  Marketed medicines that have passed bioequivalence testing should in general be substitutable. However, for a variety of reasons, caution may be warranted, particularly with regard to narrow therapeutic index drugs and the indiscriminate use of biosimilars. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharmacies concerning generic substitution. The guidelines […]

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A patient-centred paradigm for the biosimilars market

Abstract: The advent of similar biological medicinal products or ‘biosimilars’ in Europe in the 2000s has led to development of a global biosimilars market and regulatory frameworks designed specifically for approval of biosimilars. Like originator biologicals, biosimilars exhibit greater molecular complexity than small-molecule drugs, including generics. Current estimates suggest that biosimilars are more expensive and […]

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