Biosimilar Education and Curriculum Material Updates for healthcare Professional
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring updates to existing biosimilar education and curriculum materials for healthcare professionals, with a solicitation release estimated for July 1, 2026, and award targeted for January 1, 2027. The materials must reflect recent regulatory efficiency progress, including streamlined approaches that eliminate default comparative efficacy study requirements, and provide enhanced scientific explanation of biosimilar safety and efficacy to support healthcare provider uptake and acceptance.
Award value is estimated between $250,000 and $700,000. Work supports FDA's objective to enable approval of additional biosimilars and interchangeables with reduced clinical study burden and lower costs, thereby increasing patient access. Inquiries should be directed to the FDA Acquisition Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
OTBB has educational materials available for healthcare providers, including a curriculum for use in healthcare professional schools. These materials were published prior to the significant regulatory efficiency progress made in recently (e.g., no default comparative efficacy studies). These streamlined regulatory approaches make some of the material developed outdated, and also necessitates additional explanation of the scientific underpinnings that ensure safety and efficacy of biosimilar to support uptake and acceptance of biosimilars. These updates are important to support approval of more biosimilars and interchangeables without large clinical studies and lower costs and increase access for patients.
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