Review Article

The need for distinct nomenclature for originator and biosimilar products

Published in: Volume 7 / Year 2018 / Issue 4
Author(s): , , ,
Page: 152-7

Author byline as per print journal: Michael Sarshad, BSc, MBA; Rosanne Campbell, BComm, PGdip, MSc; Peter J Pitts, BA; Jacqueline anderpuye- Orgle, MSc, PhD Abstract: As the number of biosimilar… Read More »

Protein heterogeneity and the immunogenicity of biotherapeutics

Published in: Volume 7 / Year 2018 / Issue 2
Author(s):
Page: 63-9

Abstract: High resolution analytical techniques reveal structural micro-heterogeneity within endogenous proteins, however, they are ‘seen’ as ‘self’ molecules by the immune system and immunological tolerance is established. In contrast the… Read More »

The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US

Published in: Volume 7 / Year 2018 / Issue 1
Author(s): ,
Page: 22-5

Author byline as per print journal: Hajaj M Alhomaidan; Ali M Alhomaidan, PhD Abstract: This paper describes the differences in human embryonic stem cell regulations in several Christian countries across… Read More »

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

Published in: Volume 7 / Year 2018 / Issue 1
Author(s): , , , , ,
Page: 14-21

Background and aim: Biosimilar medicines are not considered exact replicas of originator biological medicines. As a result, prescribers can be hesitant to introduce such medicines into the clinical setting until… Read More »

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

Published in: Volume 6 / Year 2017 / Issue 4
Author(s):
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

Author byline as per print journal: Anu Gore, PhD; Mayssa Attar, PhD; Chetan Pujara, PhD; Sesha Neervannan, PhD Abstract: Generic drugs are intended to provide a lower cost option of safe… 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

Author byline as per print journal: Shyam Akku, MD; Amit Garg, MD; Suhas Khandarkar, MPharm Introduction: Majority of the Colombian population has become health insured leading to improved healthcare access in… 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 »

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