AUGMENT Biosimilars

Capacity building to support the uptake of biosimilars in a multistakeholder approach

Program

EU4Health

The project is funded by the European Health and Digital Executive Agency (HaDEA) under the contract HADEA/2023/OP/0040

• Duration: the project commenced on 11 July 2024 and will run for 36 months
• Project budget: 1 500 000 €

Project objective

The aim of the project is to support national authorities in implementing policies and practices that improve biosimilar competition by identifying barriers and facilitations
to increasing accessibility and affordability. 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).

Project website

Available on the website – click here.

Background

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, contributing to the sustainability of healthcare systems.

The project is implemented by an AUGMENT Consortium comprises four partner institutions, each bringing unique expertise to the project:

• Gesundheit Österreich Forschungs- und Planungs GmbH (Austria, consortium leader),
• Agency for Health Technology Assessment and Tariff System (Poland)
• Медицински университет – София (Bulgaria),
• Universidade NOVA de Lisboa(Portugal)

in close cooperation with a subgroup of the National Competent Authorities on Pricing, Reimbursement, and Public Payers (NCAPR network), namely the NCAPR Biosimilar Working Group (NCAPR BSWG), DG SANTE and HaDEA.

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.

The Agency is responsible for the implementation of the tasks of the Study on Best Policies and Practices package. The basic tasks include:

1. Systematic literature review on biosimilar uptake in 32 European countries (national policies, best practices, barriers, challenges, horizon scanning, etc.).

1. Exploratory interviews with representatives of Belgium and Finland.

1. Online stakeholder survey with a pilot phase and analysis of responses for various stakeholder groups (public authorities, health service providers, industry representatives, patients, consumers etc.). The aim is to gather stakeholder perspectives and insights on biosimilar policies and practices, providing a comprehensive understanding of the barriers and opportunities for biosimilar uptake.
2. Biosimilar country fiches for 5 European countries (Czech Republic, Latvia, Lithuania, Poland, Slovakia).

1. Organization of two study visits, one of five workshops, two of the eighteen meetings with NCAPR BSWG and two of seven discussion sessions.
2. Participation in the development of the dashboard (Power BI) an analytical tool to display biosimilar policies in the study countries and their impact on defined metrics that will support decision-making process related to biosimilar policies and practices.

The following research questions are expected to be answered as part of the implementation of this package:

• 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?

Additional activities of the Agency include participation in the implementation of work packages:

1. Project management – input related to relevant tasks to reports.
2. Coordination and dissemination – organization and participation in meetings with the NCAPR Biosimilar Working Group, discussion sessions, webinars, and co-creation of a knowledge hub within the EU Health Policy Platform (EU HPP).
3. Capacity building activities) – preparation and participation in study visits, co-creation of the “roadmap”, preparation of materials and participation in training for stakeholders, as a trainer or observer.

Representatives of the European Commission (DG SANTE and HaDEA) monitor the progress of the project, seventy-two juor fixe meetings and sixteen progress reports are planned. The final products will AUGMENT Biosimilar Knowledge Hub for public authorities, tailored roadmap for (clusters) of EU and EEA Member States to implement and optimise effective biosimilar policies and biosimilar training itineraries.

Useful links

• https://health.ec.europa.eu/events/biosimilar-medicines-multistakeholder-event-2024-12-05_en
• https://ppri.goeg.at/system/files/inline-files/Biosimilars_Glossary_final_November%202024.pdf