About this project

Background and Aim

The AUGMENT Biosimilars Project addresses the growing need for effective policies and practices to encourage the competition and uptake of biosimilars. Biosimilars are follow-up products to biological medicines, offering significant potential for cost savings and improved patient access. Despite their benefits, biosimilar uptake remains below expectations due to various barriers, including limited knowledge, lack of acceptance, and lack of trust among patients and healthcare professionals. The AUGMENT Biosimilars Project aims to identify and promote best practices to overcome these challenges, ultimately contributing to the sustainability of healthcare systems.
The project is designed to support national authorities in implementing policies and practices that improve biosimilar competition. By enhancing the accessibility, affordability, and availability of medicines, the project aims to benefit patients across the European Union (EU) and the European Economic Area (EEA).

Funding

This project is funded by the European Health and Digital Executive Agency (HaDEA) under the contract HADEA/2023/OP/0040. The project commenced on 11 July 2024, and will run for 36 months. The funding supports a comprehensive approach to studying and promoting biosimilar uptake, including research, stakeholder engagement, and capacity-building activities.

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Overview of Tasks

The project is structured into four main work packages (WPs):

  • WP1: Project Management - This work package ensures the timely delivery of high-quality outputs and effective coordination among consortium members. It includes tasks such as project kick-off, communication and meetings, interim and final reports, and data management.
  • WP2: Coordination and Dissemination - Focused on stakeholder engagement and information dissemination, this work package includes supporting and consulting with the National Competent Authorities on Pricing and Reimbursement and Public Healthcare Payers’ Biosimilar Working Group (NCAPR BSWG), creating a thematic stakeholder network on the EU Health Portal, and developing a corporate identity for the project.
  • WP3: Study on Best Policies and Practices - This work package involves conducting comprehensive research to identify effective policies and practices for biosimilar uptake. It includes tasks such as desk research (including literature review and the development of country fiches), field research (including stakeholder survey and interviews), drawing best practices and recommendations based on the previous tasks, developing a dashboard, and disseminating study results. 
    Main research questions of this study include:
    • Which policies and practices have been implemented to encourage biosimilar development and market entry, competition and uptake in the study countries?
    • How do biosimilar policies and practices contribute to savings and increased patient access?
    • What are the barriers to, and facilitators for optimising biosimilar policies and practices?
    • What is the outlook for biosimilars in the next decade?
    • What are the best practices to optimise biosimilar policies and practices?
  • WP4: Capacity Building Activities - This work package is based on the findings of WP3 and aims to organize trainings and workshops to build capacity among stakeholders. It includes tasks such as study visits, workshops, tailored roadmaps, biosimilar training itineraries, and the production of instructional materials and support tools for trainers.

Stakeholder Groups Targeted

The project targets a wide range of stakeholders, including policymakers, healthcare professionals, patient groups, and industry representatives. By engaging these groups, the project aims to gather diverse insights and foster collaboration. The involvement of these stakeholders is crucial for understanding the barriers to biosimilar uptake and identifying best practices that can be implemented across different healthcare systems.