Meeting Report
Value-added medicines: how repurposed medicines bring value to patients and pharmacists
Author(s): Christoph Stoller, Emilia Minodora Voiculescu, PharmD, Professor Stephan Krähenbühl, MD, PhD
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 »
Roundtable on registries: practical considerations for registries – making them work, London, UK, 26 January 2017
Author(s): Clare Jacklin, Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP, Keith Bodger, MBChB(Honours), MD, FRCP, Professor John G Williams, CBE, FRCP, Professor Kimme Hyrich, MD, PhD, FRCPC, Professor Sarah Garner, BPharm, PhD, Stuart Bloom, DM, FRCP
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?
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
Author(s): José Vicente Moreno-Muelas, MD, Kevin Klein, PhD, Olga Delgado Sanchez, PharmD, Professor Francisco José de Abajo, MD, MPH, PhD, Professor Francisco Zaragozá, PhD, Professor Joan Albanell, MD, Professor Maria Jesús Sanz Ferrando, PhD, Robin Thorpe, PhD, FRCPath, Sol Ruiz, PhD
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
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
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
Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath
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
Author(s): Niklas Ekman, PhD, Paul Cornes, MD, Professor Arnold G Vulto, PharmD, PhD, FCP
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 »
Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016
Author(s): Adjunct Professor Pekka Kurki, MD, PhD, Cristina Avendaño-Solá, MD, PhD, Elena Wolff-Holz, MD, Martina Weise, MD, Niklas Ekman, PhD, Professor Andrea Laslop, MD, Professor Ferdinand Breedveld, MD, PhD, Professor Fernando Gomollón, MD, PhD, Professor Lluís Puig, MD, PhD, Professor Tore Kristian Kvien, MD, Robin Thorpe, PhD, FRCPath, Thijs J Giezen, PharmD, PhD, MSc, Vito Annese, MD
Page: 74-83
Author byline as per print journal: Vito Annese, MD, PhD; Cristina Avendaño-Solá, MD, PhD; Professor Ferdinand Breedveld, MD; Niklas Ekman, PhD; Thijs J Giezen, MSc, PharmD, PhD; Professor Fernando Gomollón, MD,… Read More »