Over 15 years ago, the world’s first biosimilar was launched. This was very much a European success story, with the European Medicines Agency leading the way to bringing more affordable biologics to patients. Biosimilars have had a tremendous impact … [Lees meer...] over15 years of Biosimilars

OVERVIEW OF EU APPROVED BIOSIMILARS – update as of 18 January 2022 (based on CHMP 13-16 December 2021 meeting) Currently, there are 71 biosimilar products that have been authorized for marketing in all EU Member States, as well as in the Economic … [Lees meer...] overOverview of EU approved Biosimilars – update as of 18 January 2022 (based on CHMP 13-16 December 2021 meeting)

Het gebruik van rituximab biosimilars (R-biosimilars) als eerstelijnsbehandeling bij patiënten met diffuus grootcellig B-cel lymfoom (DLBCL, een bepaalde vorm van lymfeklierkanker) bespaart kosten zonder de overlevingsuitkomsten van de patiënt te … [Lees meer...] overGoedkopere rituximab biosimilars geven vergelijkbare overleving bij patiënten met diffuus grootcellig B-cel lymfoom

Introduction In 2017, the European Medicines Agency approved rituximab biosimilars (R-biosimilars) for treatment of diffuse large B-cell lymphoma (DLBCL). Thereafter, the Netherlands was one of the first countries to implement … [Lees meer...] overImpact of rituximab biosimilars on overall survival in diffuse large B-cell lymphoma: a Dutch population-based study

Introduction April 2021 marked the 15th anniversary of the first biosimilar approval in Europe and, by extension, worldwide. In the US, the first biosimilar approval followed in 2015. Biosimilars are highly similar versions of originator … [Lees meer...] overCommentary: Interchangeability of Biosimilars: Overcoming the Final Hurdles

Abstract Over time, clinicians have become increasingly comfortable embracing the prescription of biosimilars—highly similar versions of innovator or reference biological agents—for their patients with inflammatory diseases. Although a switch from … [Lees meer...] overBiosimilar‐to‐Biosimilar Switching: What is the Rationale and Current Experience?

Background: Biosimilars have been used for 15 years in the European Union (EU), and have been shown to reduce costs and increase access to important biological medicines. In spite of their considerable exposure and excellent safety record, many … [Lees meer...] overSafety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective

Via deze link komt u bij de presentatie Uitwisselbaarheid Biosimilars in de EU anno 2021 gehouden door Prof. Dr. Arnold G. Vulto FCP met dank aan Liese Barbier. … [Lees meer...] overUitwisselbaarheid Biosimilars in de EU anno 2021 Arnold Vulto en Liese Barbier

    Via deze link komt u bij de presentatie IBN Beleidspunt: Duurzaamheid van de Biosimilar-markt gehouden door Prof. Dr. Arnold G. Vulto FCP met dank aan Liese Barbier. … [Lees meer...] overIBN Beleidspunt: Duurzaamheid van de Biosimilar-markt

    Via deze link komt u bij de presentatie Indicatie-extrapolatie Off-label use Avastin in het oog en biosimilars gehouden door Prof. Dr. Arnold G. Vulto FCP.     Via deze link komt u bij de update van de … [Lees meer...] overIndicatie-extrapolatie Off-label use Avastin in het oog en biosmilars