Meeting Report

First GCC Stakeholder Meeting on Approval Process, Interchangeability/Substitution and Safety of Biosimilars 2017 – Report

Published in: Volume 7 / Year 2018 / Issue 4
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Page: 158-63

Author byline as per print journal: Gianluca Trifirò, MD, PhD; Meteb Al-Foheidi, MD, FRCPC; Ali M Alhomaidan, PhD; Ahmed H Aljedai, PharmD, MBA, BCPS, FCCP, FAST; Musaed Abdullah Alkholief, PhD;… Read More »

First ASEAN educational workshop on regulation and approval of biosimilars/similar biotherapeutic products 2017 – Report

Published in: Volume 7 / Year 2018 / Issue 3
Author(s): , ,
Page: 127-32

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Elwyn Griffiths, PhD, DSc; Niklas Ekman, PhD Abstract: Biosimilar medicines are being increasingly developed and used worldwide. Many regulatory agencies across… Read More »

Quality assessment of biosimilars in Colombia – reducing knowledge gaps

Published in: Volume 7 / Year 2018 / Issue 2
Author(s): , ,
Page: 79-83

Abstract: Biosimilar medicines are having a global effect, and as such regulatory agencies worldwide are assessing how to respond to them. Here, two events held by GaBI for the Colombian… Read More »

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… 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
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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
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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
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Page: 31-7

Author byline as per print journal: Professor Francisco José de Abajo, MD, MPH, PhD; Professor Joan Albanell, MD; Olga Delgado Sanchez, PharmD; Kevin Klein, MSc; José Vicente Moreno-Muelas, MD; Sol Ruiz, PhD; Professor… 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 »

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