Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016

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, PhD; Research Professor Pekka Kurki, MD, PhD; Professor Tore Kristian Kvien, MD; Professor Andrea Laslop, MD; Professor Lluís Puig, MD, PhD; Robin Thorpe, PhD, FRCPath; […]


Biosimilars for prescribers

Abstract: Biosimilars are copies of original biological medicines. Biosimilarity is a new concept in drug development. Physicians prescribing biologicals need more neutral information on the quality, safety and efficacy of biosimilars. Submitted: 27 November 2014; Revised: 15 December 2014; Accepted: 18 December 2014; Published online first: 19 December 2014 Introduction The European Union (EU) was […]


2nd MENA Stakeholder Meeting on Biosimilars 2018 – Report

Introduction: The number of biosimilars, or similar biotherapeutic products, is expanding rapidly worldwide. A further 12 blockbuster biologicals are set to add to this number by 2020. Agreement about the best practices for the regulation, use, interchangeability and pharmacovigilance of biosimilars is lacking in many countries including in the Middle East and North Africa (MENA). […]