Short description
Capacity building to support the uptake of biosimilars in a multistakeholder approach.
Biosimilar medicines have a similar efficacy and safety compared with their reference medicines and hold the potential to achieve significant savings for health systems and improve access to medicines for patients. Still, barriers remain and, to a certain extent, impede their successful entry into the market and uptake by health systems. This call for tenders aims to support national authorities in implementing policies and practices that improve biosimilar competition, as a means to contribute to the accessibility, affordability and availability of medicines for patients in the EU.
It will do so by proposing a series of capacity-building activities, based on best-practices and recommendations drawn from an analysis of current national biosimilar policies and their impact on savings and access.
More specifically, the requested tasks include:
1. a study mapping the different national policies and practices to improve biosimilar competition, determining their (combined) impact in terms of savings and improving access, identifying barriers to entry and optimisation of competition, and looking at key trends and losses of exclusivity for the near future;
2. educational toolkits developed by national experts to gather relevant and understandable scientific and regulatory information for healthcare professionals and patients;
3. practical workshops and study visits to enable mutual learning and best-practice exchange between national authorities;
4. tailored roadmaps describing the steps that can be taken at national level and by the different stakeholders to enable biosimilar competition from day one following loss of exclusivity;
5. and training itineraries as well as a deployment plan incorporating all lessons learned from the previous activities, to ensure continued awareness and use of the deliverables.
An overall task for the entire duration of this project (extended to 36 months), will be to ensure coordination and coherence between the different tasks, taking due account of relevant stakeholder input, as well as disseminating the resulting materials.
2023-09-15 04:16
Biosimilar medicines have a similar efficacy and safety compared with their reference medicines and hold the potential to achieve significant savings for health systems and improve access to medicines for patients. Still, barriers remain and, to a certain extent, impede their successful entry into the market and uptake by health systems. This call for tenders aims to support national authorities in implementing policies and practices that improve biosimilar competition, as a means to contribute to the accessibility, affordability and availability of medicines for patients in the EU. It will do so by proposing a series of capacity-building activities, based on best-practices and recommendations drawn from an analysis of current national biosimilar policies and their impact on savings and access. More specifically, the requested tasks include: 1. a study mapping the different national policies and practices to improve biosimilar competition, determining their (combined) impact in terms of savings and improving access, identifying barriers to entry and optimisation of competition, and looking at key trends and losses of exclusivity for the near future; 2. educational toolkits developed by national experts to gather relevant and understandable scientific and regulatory information for healthcare professionals and patients; 3. practical workshops and study visits to enable mutual learning and best-practice exchange between national authorities; 4. tailored roadmaps describing the steps that can be taken at national level and by the different stakeholders to enable biosimilar competition from day one following loss of exclusivity; 5. and training itineraries as well as a deployment plan incorporating all lessons learned from the previous activities, to ensure continued awareness and use of the deliverables. An overall task for the entire duration of this project (extended to 36 months), will be to ensure coordination and coherence between the different tasks, taking due account of relevant stakeholder input, as well as disseminating the resulting materials.
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Biosimilar medicines have a similar efficacy and safety compared with their reference medicines and hold the potential to achieve significant savings for health systems and improve access to medicines for patients. Still, barriers remain and to a certain extent impede their successful entry to the market and uptake by health systems. This call for tenders aims to support national authorities in implementing policies and practices that improve biosimilar competition, as a means to contribute to the accessibility, affordability and availability of medicines for patients in the European Union. It will do so by proposing a series of capacity-building activities, based on best-practices and recommendations drawn from an analysis of current national biosimilar policies and their impact on savings and access. More specifically, the requested tasks will include: 1. A study mapping the different national policies and practices to improve biosimilar competition, determining their (combined) impact in terms of savings and improving access, identifying barriers to entry and optimisation of competition, and looking at key trends and losses of exclusivity for the near future; 2. Practical workshops and study visits to enable mutual learning and best-practice exchange between national authorities; 3. Tailored roadmaps describing the steps that can be taken at national level and by the different stakeholders to enable biosimilar competition from day one following loss of exclusivity; 4. And training itineraries as well as a deployment plan incorporating all lessons learned from the previous activities, to ensure continued awareness and use of the deliverables. An overall task for the entire duration of this project (limited to 36 months), will be to ensure coordination and coherence between the different tasks, taking due account of relevant stakeholder input, as well as disseminating the resulting materials.