AOTMiT – we build capacity in the field of biosimilars

Agency for Health Technology Assessment and Tariff System is actively involved in activities aimed at improving patient access to modern, effective, and safe biological therapies.

Through its participation in the AUGMENT Biosimilars project, the Agency supports the development of evidence-based health policies that strengthen confidence in biosimilars and enable their wider use in clinical practice, benefiting patients and healthcare systems.

Biosimilars are playing an increasingly important role in healthcare systems. They enable wider patient access to effective and safe biological therapies, while maintaining comparable quality, efficacy, and safety to reference medicines, as confirmed by rigorous testing and clinical evaluation.

The activities undertaken as part of the AUGMENT Biosimilars project, in which AOTMiT is actively involved, aim to remove barriers to the use of biosimilars. In practice, this means working on solutions that:

• increase patient confidence in biosimilars through reliable information about their efficacy and safety,
• support the decisions of doctors and pharmacists to make biosimilar therapies a viable and accessible treatment option,
• enable wider availability and affordability of these therapies.

The first year of the project focused on extensive research into policies related to the implementation and deployment of biosimilars, which resulted in the publication of the Final Study Report.

Through these activities, the AUGMENT project supports the development of health policies that put the patient at the center of the system. The ultimate goal is to make modern biological therapies, including biosimilars, more accessible.

You can find out more about the role of AOTMiT in the AUGMENT Biosimilars project at: https://www.aotm.gov.pl/projekty-unijne/biosimilars/

Official website of the AUGMENT Biosimilars project: https://biosimilars.goeg.at/

Documents to download:

• Final study report: https://op.europa.eu/en/publication-detail/-/publication/b6eb292e-cff4-11f0-8da2-01aa75ed71a1/language-en.
• Appendix 7: https://op.europa.eu/en/publication-detail/-/publication/06073c84-cff5-11f0-8da2-01aa75ed71a1/language-en
• Annexes 1-6 and 8-11: https://op.europa.eu/en/publication-detail/-/publication/a87f24e3-cff4-11f0-8da2-01aa75ed71a1/language-en