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 Division at the Federal Institute for Drugs and Medical Devices (BfArM), discussed at the 14th Annual Biosimilar Medicines Group Conference. Submitted: 1 December 2016; Revised: […]
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: 23 January 2017; Accepted: 24 January 2017; Published online first: 6 February 2017 Introduction Labels on medicinal products contain information for pharmacists, physicians and patients. […]
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 of biosimilarity, its step-wise approach to the approval process and factors/issues that should be considered when providing scientific justification for extrapolation. Submitted: 22 September 2016; […]
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 as a key issue. Submitted: 4 June 2016; Revised: 7 September 2016; Accepted: 15 September 2016; Published online first: 28 September 2016 Introduction This interactive […]
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 Group (formerly EBG) satellite symposium at the European Association of Hospital Pharmacists’ 2016 Vienna conference. Using biosimilars as a way to reduce pharmaceutical expenditure was […]
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; […]
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 including in the Middle East and North Africa (MENA). Methods: The first MENA educational workshop on SBPs was held in Dubai, UAE on 1 September […]
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 2015; Accepted: 15 July 2015; Published online first: 28 July 2015 The European Generic medicines Association (EGA) held its 13th EGA–European Biosimilars Group Conference in […]
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 first in a series of educational workshops on SBPs in Latin America was held in Mexico City on 20 January 2015. Didactic presentations covered the […]
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 impressive number of interesting Symposia, State-of-the-Art Lectures as well as Plenary and Poster Sessions covering all aspects of basic and clinical research and care of […]
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; Mohammad A Alsenaidy, MSc, PhD; Aws Alshamsan, BPharm, RPh, PhD; Tore Kristian Kvien, MD, PhD Introduction: A meeting was organized by the Generics and Biosimilars […]
Introduction: The Association of Southeast Asian Nations (ASEAN) Overview Workshop on GMP for Biologicals and Biosimilars was co-organized with the Generics and Biosimilars Initiative (GaBI). This meeting was intended to improve the understanding of the good manufacture practice (GMP) inspection framework for biological (and biosimilar) drugs among ASEAN countries. Methods: The workshop was held on […]
