Review Article

Published in:
Volume 4 / Year 2015 / Issue 3

Biosimilars: extrapolation of clinical use to other indications

Author(s): , ,
Page: 118-24

Abstract: Biosimilars should be approved for all the clinical indications of the reference product based on the totality of the evidence even if there is no clinical safety and efficacy… Read More »

Biosimilars patent litigation in the EU and the US: a comparative strategic overview

Page: 113-7

Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by regulatory bodies, such as the US Food and Drug Administration. Biosimilar… Read More »

Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future

Author(s): ,
Page: 125-35

Author byline as per print journal: Brian Godman, BSc, PhD; Michael Wilcock, MPharm; Andrew Martin, MPharm; Scott Bryson, MSc, MPH; Christoph Baumgärtel, MD; Tomasz Bochenek, MD, MPH, PhD; Winne de Bruyn, BSc;… Read More »

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