Abstract:
Biosimilar medicines, that is biologicals marketed following the loss of exclusivity of the originator biological, offer the potential to improve patient access to biological therapies at more affordable prices. Despite this promise, challenges to biosimilar uptake persist across Europe.
The project “Capacity building to support the uptake of biosimilars in a multistakeholder approach” (“AUGMENT Biosimilars” for short) aims to support national public authorities in their implementation of policies and practices that improve biosimilar uptake and competition as a means to contributing to the accessibility, affordability and availability of medicines for patients in Europe.
This study was conducted as part of the AUGMENT Biosimilars project. It maps current national policies and practices implemented for biosimilars in 32 European countries (EU member states, EFTA countries and the United Kingdom) and analyses their impact in terms of savings and improved patient access. The study identifies barriers to biosimilar uptake, highlights good practice examples and provides an outlook on biosimilars in development. The study questions were addressed using a mixed-methods approach, including systematic and narrative literature reviews, quantitative data analyses, interviews and an online stakeholder survey. The study concludes with recommendations aimed at optimising biosimilar uptake and competition.