Using real-world data from multiple countries to improve biosimilar product approvals
Official title: Bridging the Gap: Using Foreign Real-World Data to Inform Interchangeable Biosimilar Approvals
Funded at Academy of Managed Care Pharmacy, INC. · NIH-10832215 · Data updated 2026-11-12
This study is looking at how real-world information from the U.S., Italy, and Denmark can help make it easier and faster for new biosimilar medicines to get approved, so patients can have more options for their treatments.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Academy of Managed Care Pharmacy, INC. NIH-funded |
| Lab location | 1 site (Alexandria, United States) |
| Project start | September 15, 2023 |
| Project end | August 31, 2025 |
| Funding year | 2023 |
| Award (this year) | $1,452,600 |
| NIH project number | 1U01FD008041-01 |
| Project ID | NIH-10832215 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are patients who may benefit from biosimilar medications, particularly those with conditions requiring biologic treatments.
✕Less likely to help
Patients who are not seeking treatment with biosimilars or those who do not have access to these medications may not benefit from this research.
What this research studies
This research investigates how real-world data (RWD) from the U.S., Italy, and Denmark can be utilized to enhance the regulatory approval process for interchangeable biosimilars. By evaluating the feasibility and validity of using foreign RWD, the study aims to develop a common data model and shared protocol for conducting biosimilar interchangeability studies. The findings will inform recommendations for the FDA on integrating international data into their decision-making processes, potentially leading to more efficient approvals of biosimilars.
Why it matters
Potential benefit: If successful, this research could streamline the approval process for biosimilars, making them more accessible and affordable for patients.
How similar studies have gone: While the use of real-world data in regulatory processes is gaining traction, this specific approach of integrating foreign RWD for biosimilar approvals is relatively novel and has not been extensively tested.
Where this research is happening
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Academy of Managed Care Pharmacy, INC.
Alexandria, United States Active
Researchers
- Principal investigator: Lockhart, Catherine Marie — Academy of Managed Care Pharmacy, INC.
- Study coordinator: Lockhart, Catherine Marie
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.