Laatste nieuws

Via deze link krijgt u de eindrapportage van het Programma Biosimilars op Maat zoals IBN en IVM dat samen hebben uitgevoerd van 2018 – 2021. In de Eindrapportage kunt u lezen over de gekozen aanpak, welke leermiddelen er in het kader van het programma zijn gemaakt (zie ook onder aan deze pagina) en de resultaten […]

Isabell Remus, Chair of the Biosimilar Medicines Sector group of Medicines for Europe, said: “The access gaps will not close by themselves, this requires conscious policy-making that puts biosimilar medicines – and patients — at the centre. This can only happen with strong political leadership to drive the right mix of policies. The European Commission has been a strong ally in the past 15 years and we very much count on its leadership to keep shaping the right environment for biosimilars over the next 15 years.”

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 Area countries Iceland, Liechtenstein and Norway. Based on the latest publicly available information, 14 biosimilar candidates are currently under evaluation at the European Medicines Agency.

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 beïnvloeden.

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 R-biosimilars, given lower costs compared with rituximab originator (R-originator).

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 biological medicines, which are approved according to the same standards of pharmaceutical quality and have comparable efficacy and safety in patients.

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.

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.

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.