Meeting Report

Perspectives on the future of pegfilgrastim biosimilars

Published in: Volume 6 / Year 2017 / Issue 4
Author(s): , ,
Page: 185-7

Author byline as per print journal: Professor Pere Gascón, MD; Ruediger Jankowsky, PhD; Karsten Roth, PhD Abstract: Cinfa Biotech, the biosimilars specialists of the Cinfa Group, reviewed pegfilgrastim biosimilar approaches to treat… Read More »

Value-added medicines: how repurposed medicines bring value to patients and pharmacists

Published in: Volume 6 / Year 2017 / Issue 3
Author(s): , ,
Page: 141-6

Author byline as per print journal: Christoph Stoller; Professor Stephan Krähenbühl, MD, PhD; Emilia Minodora Voiculescu, PharmD Abstract: The Value Added Medicines Group of Medicines for Europe met at the 2017 European… Read More »

Pharmacovigilance, traceability and building trust in biosimilar medicines

Published in: Volume 6 / Year 2017 / Issue 3
Author(s): , ,
Page: 135-40

Author byline as per print journal: Professor Teun van Gelder, MD, PhD; Benedicte Lunddahl, DVM; Professor Barbara OM Claus, PharmD, PhD Abstract: The Medicines for Europe’s Biosimilar Medicines Group met at the… Read More »

Roundtable on registries: practical considerations for registries – making them work, London, UK, 26 January 2017

Published in: Volume 6 / Year 2017 / Issue 3
Author(s): , , , , , ,
Page: 122-34

Author byline as per print journal: Stuart Bloom, DM, FRCP; Keith Bodger, MBChB(Honours), MD, FRCP; Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP; Professor Sarah Garner, BPharm, PhD; Professor Kimme Hyrich, MD, PhD, FRCPC; Clare… Read More »

Biosimilar product labels in Europe: what information should they contain?

Published in: Volume 6 / Year 2017 / Issue 1
Author(s):
Page: 38-40

Abstract: In 2016, a multi-stakeholder workshop was held on the topic of ‘Biosimilar Labelling’. The discussions concerning labelling particulars are outlined in this meeting report. Submitted: 21 November 2016; Revised:… Read More »

Roundtable on biosimilars: pharmacovigilance, traceability, immunogenicity, 15 November 2016, Madrid, Spain

Published in: Volume 6 / Year 2017 / Issue 1
Author(s): , , , , , , , ,
Page: 31-7

Introduction: Biosimilars can offer a lower-cost alternative to current biological therapies and could help contribute to the much-needed savings for the healthcare systems. All biosimilars approved by the regulators must… Read More »

Data requirements to demonstrate biosimilarity in the EU

Published in: Volume 5 / Year 2016 / Issue 4
Author(s):
Page: 182-4

Abstract: How has the European Medicines Agency (EMA) changed its requirements for biosimilars since it first approved biosimilars in 2006? This is the question Dr Martina Weise, Head of Licensing… Read More »

Demonstrating interchangeability and biosimilarity for US biosimilars

Published in: Volume 5 / Year 2016 / Issue 3
Author(s):
Page: 139

Abstract: The US Food and Drug Administration (FDA) outlines its approach to biosimilarity and interchangeability at the 2016 Generic Pharmaceutical Association Biosimilars Council Conference. Topics covered include the FDA definition… Read More »

First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, 2–3 March 2016, Ankara, Turkey

Published in: Volume 5 / Year 2016 / Issue 3
Author(s): ,
Page: 134-8

Abstract: This paper discusses the findings and summary of items covered in the First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, in which structure–function was highlighted… Read More »

Reducing healthcare costs and building trust in biosimilar medicines

Published in: Volume 5 / Year 2016 / Issue 2
Author(s): , ,
Page: 84-8

Author byline as per print journal: Niklas Ekman, PhD; Professor Arnold G Vulto, PharmD, PhD; Paul Cornes, MD Abstract: The increasing cost of medicines was highlighted at the Biosimilar Medicines… Read More »

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