Review Article

Cost-minimization analysis of generic equivalents (bortezomib, decitabine and capecitabine) in comparison to the originator brand medicines in Colombia

Published in: Volume 5 / Year 2016 / Issue 4
Author(s): , ,
Page: 164-7

Introduction: Majority of the Colombian population has become health insured leading to improved healthcare access in the country. Healthcare expenses have risen drastically, and cancer is responsible for the major… Read More »

The generic medicines system in Italy: scenarios for sustainable growth

Published in: Volume 5 / Year 2016 / Issue 3
Author(s): , ,
Page: 114-22

Author byline as per print journal: Federico Fontolan1, MA; Silvia Zucconi1, MStat; Carlo Piccinni2, PhD Abstract: In this paper, an overview is provided of the present Italian generic medicines system.… Read More »

Current state of subsequent entry biologics (biosimilars) in Canada: a view from regulatory, reimbursement, clinician, and patient perspectives

Published in: Volume 5 / Year 2016 / Issue 3
Author(s): ,
Page: 105-13

Abstract: Biological molecules represent a significant portion of therapies utilized in Canada. Biosimilars, also known as subsequent entry biologics (SEBs) in Canada, are highly comparable versions of the originator products.… Read More »

Assessment of the interchangeability between generics

Published in: Volume 5 / Year 2016 / Issue 2
Author(s): , , , , , , ,
Page: 55-9

Author byline as per print journal: Luther Gwaza1,2, BPharm, MPhil; John Gordon3, PhD; Henrike Potthast4, PhD; Marc Maliepaard5, PhD; Jan Welink5, Hubert Leufkens1,5, PhD; Matthias Stahl6, MD; Alfredo García-Arieta7, PhD… Read More »

Life begins at forty – hybridomas: ageing technology holds promise for future drug discoveries

Published in: Volume 5 / Year 2016 / Issue 1
Page: 21-6

Abstract: Hybridomas were developed in 1975 as a stable platform for creating monoclonal antibodies (mAbs). Over the past 40 years, hybridomas have been a leading platform for creating mAbs, yet… Read More »

Biosimilars: extrapolation of clinical use to other indications

Published in: Volume 4 / Year 2015 / Issue 3
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

Published in: Volume 4 / Year 2015 / Issue 3
Author(s): ,
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

Published in: Volume 4 / Year 2015 / Issue 3
Author(s): ,
Page: 125-35

Introduction: The manufacturer of pregabalin has a second use patent covering prescribing for neuropathic pain – its principal indication. The manufacturer has threatened legal action in the UK if generic… Read More »

The refinement of the super generic concept: semantic challenge for product re-innovation?

Published in: Volume 4 / Year 2015 / Issue 1
Author(s): ,
Page: 25-32

Background: Uptake of super generic or hybrid pharmaceuticals has decelerated despite their important economic potential for the generic pharmaceutical industry. The aim of switching to these product portfolios was to… Read More »

Safety assessment of biosimilars in Europe: a regulatory perspective

Published in: Volume 3 / Year 2014 / Issue 4
Author(s): ,
Page: 180-3

Abstract: Clinical safety is important during the development of a biosimilar. This paper provides an overview of the main aspects related to the safety assessment of biosimilars. The European Medicines… Read More »

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