Meeting Report
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 »
First MENA educational workshop on regulation and approval of similar biotherapeutic products/biosimilars, Dubai, United Arab Emirates, 1 September 2015
Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath
Page: 173-7
Introduction: Similar biotherapeutic products (SBPs or biosimilars) include a rapidly expanding number of therapeutic products worldwide. However, agreement about the best practices for their regulation are lacking in many countries… Read More »
European biosimilars conference highlights extrapolation as key issue
Abstract: This paper discusses topics covered by the EGA’s April 2015 biosimilars conference, where extrapolation of indications was highlighted as a key issue. Submitted: 2 July 2015; Revised: 15 July… Read More »
First Latin American educational workshop on similar biotherapeutic products, Mexico City, Mexico, 20 January 2015
Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath
Page: 143-8
Introduction: Similar Biotherapeutic Products (SBPs or biosimilars) comprise a rapidly expanding area of therapeutics worldwide. However, best practices for their regulation are lacking in many Latin American countries. Methods: The… Read More »
2014 World Transplant Congress, San Francisco, California, USA, 26–31 July 2014
This was a joint meeting of the American Society of Transplant Surgeons (ASTS), The Transplant Society (TTS) and the American Society of Transplantation (ATS). The Congress was packed with an… Read More »