Review Article

Major lessons learned from Zarxio’s US launch: the start of a biosimilar revolution

Published in: Volume 6 / Year 2017 / Issue 4
Page: 165-73

Introduction: Launched in 2015, Zarxio™ (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval. In contrast, the first biosimilar was launched in Europe in 2006.… Read More »

Biosimilars in Italy: what do real-world data reveal?

Published in: Volume 6 / Year 2017 / Issue 3
Author(s): , , ,
Page: 114-9

Author byline as per print journal: Assistant Professor Gianluca Trifirò, MD, PhD; Ylenia Ingrasciotta, MSc; Ilaria Marcianò, MSc; Armando Genazzani, DPhil, MD Abstract: This paper aims to provide an overview of… Read More »

Ocular emulsions and dry eye: a case study of a non-biological complex drug product delivered to a complex organ to treat a complex disease

Published in: Volume 6 / Year 2017 / Issue 1
Author(s): , , ,
Page: 13-23

Abstract: Generic drugs are intended to provide a lower cost option of safe and effective medicines thereby granting greater patient access to affordable health care. A sound scientific basis and… Read More »

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 »

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