Search results for Meeting Report

Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health

Introduction: In the US, some biosimilars that meet additional requirements may be approved as interchangeable products. This means they can undergo pharmacy-level substitution. An online webinar titled ‘Biosimilar Red Tape Elimination Act (S.2305): Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health’, was held to discuss its implications on medicines availability, safety […]

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Medicare drug price negotiations: impact on healthcare development and patient access to medicines

Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Esq; Steven J Potts, PhD, MBA; Andrew Spiegel, Esq Introduction: In the US, a Medicare drug price negotiation provision has been introduced in the form of the 2022 Inflation Reduction Act (IRA). An online webinar on the […]

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Non-medical switching of biologicals/biosimilars: Canada, Europe and the US – a webinar report

Author byline as per print journal: Michael S Reilly, Esq; Gail Attara; Ralph D McKibbin, MD, FACP, FACG, AGAF; Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP Introduction: Biosimilars are now key players in the global drugs market offering potentially more affordable treatment options with similar safety and efficacy. However, there are concerns about non-medical […]

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Key factors for successful uptake of biosimilars: Europe and the US

Introduction: Biosimilars were first introduced in Europe in 2006 and then in the US in 2015. An online webinar on the successful uptake in Europe and the US was held to discuss measures taken for improving biosimilar uptake, and trends in uptake. Methods: The webinar was held by the Alliance for Safe Biologic Medicines (ASBM) […]

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3rd Colombian educational workshop on regulatory assessment of biosimilars 2019 – Report

Author byline as per print journal: Professor John-Joseph Borg, PhD; Yolanda Elias Gramajo, MD; Professor Andrea Laslop, MD; Robin Thorpe, PhD, FRCPath; Jian Wang, MD, PhD Introduction: Biosimilars have the potential to improve access to medicines for many across the globe. However, work is required to ensure adequate regulation, pharmacovigilance and education about biosimilars. Colombia […]

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

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 the globe are assessing how policy and regulation can be adapted and developed to ensure that biosimilars can enter markets successfully, without affecting the safety […]

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Quality assessment of biosimilars in Colombia – reducing knowledge gaps

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 medicines regulatory agency (INVIMA) are reported. The first was an educational workshop held in 2016 to discuss approaches to evaluating biosimilar products and the second […]

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Perspectives on the future of pegfilgrastim biosimilars

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 treat chemotherapy-induced neutropenia. Professor Dr Gascón discussed ’perspectives of pegfilgrastim’ and Dr Roth and Dr Jankowsky discussed why biosimilars are vital for oncology care. Submitted: […]

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Value-added medicines: how repurposed medicines bring value to patients and pharmacists

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 Association of Hospital Pharmacists conference in France to discuss the merits and future of these medicines. Submitted: 13 June 2017; Revised: 23 August 2017; Accepted: […]

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Pharmacovigilance, traceability and building trust in biosimilar medicines

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 2017 European Association of Hospital Pharmacists conference in France to discuss pharmacovigilance, traceability and building trust in biosimilar medicines. Submitted: 22 May 2017; Revised: 21 […]

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Roundtable on registries: practical considerations for registries – making them work, London, UK, 26 January 2017

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 Jacklin; Professor John G Williams, CBE, FRCP Introduction: Registries collect clinical data to evaluate specified outcomes for a population defined by a particular disease, condition […]

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Roundtable on biosimilars: pharmacovigilance, traceability, immunogenicity, 15 November 2016, Madrid, Spain

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 Maria Jesús Sanz Ferrando, PhD; Robin Thorpe, PhD, FRCPath; Professor Francisco Zaragozá, PhD Introduction: Biosimilars can offer a lower-cost alternative to current biological therapies and could […]

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