Multistakeholder Engagement in Biosimilar Policy Development

In advancing biosimilar policy development across Europe, the AUGMENT Biosimilars project identifies effective measures to overcome barriers to uptake, lower costs, and expand patient access to follow-on biological medicines. The three-day INFARMED study visit exemplifies this collaborative model by convening Portuguese hospitals, regulators, therapeutic committees, digital health services, patient organisations, and professional associations.

Four work packages executed by a consortium of Gesundheit Österreich, the Polish Agency for Health Technology Assessment and Tariffication, the Medical University of Sofia, and Universidade NOVA de Lisboa combine desk research, stakeholder surveys, and structured visits. A dedicated EU Health Policy Platform knowledge hub ensures continuous interaction and triangulation of findings from literature, surveys, and real-world observation.

Portuguese Realities Shaping Biosimilar Uptake

Discussions at INFARMED and Unidade Local de Saúde Santa Maria revealed how regulatory, clinical, and operational factors interact within the National Health Service. The breadth of participating institutions underscores that barriers are multifaceted and best addressed through coordinated national strategies.

Capacity Building as Engine of Biosimilar Policy Development

Stakeholder-derived evidence from the visit equips national authorities to design reimbursement, procurement, and educational interventions that accelerate uptake. The resulting roadmaps, training materials, and networks will help embed economic insights into routine decisions, supporting sustainable financing of biological therapies while widening treatment options.