Developing a platform to evaluate biosimilar drug products
Platform for reliable characterization and evaluation of comparability of biosimilar drug products in lyophilized and liquid formulations
This study is working on new ways to make sure that biosimilar drugs—medications that are similar to existing ones—are just as safe and effective for patients, by finding and fixing issues that can affect how we test them.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | National Institute for Pharm Tech/educ NIH-funded |
| Lab location | 1 site (Minneapolis, UNITED STATES) |
| Project ID | NIH-10619335 on NIH RePORTER |
What this research studies
This research focuses on creating a reliable platform to characterize and evaluate the comparability of biosimilar drug products, which are biologic medications that are similar to already approved reference products. The project aims to address challenges posed by excipients in drug formulations that can interfere with standard analytical methods. By identifying these challenges, the research will develop new analytical tools to ensure that biosimilars are comparable to their reference counterparts without clinically meaningful differences. This work is crucial for ensuring the safety and efficacy of biosimilars for patients.
Who could benefit from this research
Good fit: Ideal candidates for benefiting from this research are patients who require biologic therapies that may be available as biosimilars.
Not a fit: Patients who are not seeking biologic therapies or those who are not eligible for biosimilar treatments may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to more reliable biosimilar products, potentially increasing access to effective treatments for patients.
How similar studies have performed: While the approach to developing a platform for biosimilar evaluation is innovative, similar research has shown promise in improving the characterization of biologic products.
Where this research is happening
Minneapolis, UNITED STATES
- National Institute for Pharm Tech/educ — Minneapolis, United States (Active)
Researchers
- Principal investigator: Suryanarayanan, Raj — National Institute for Pharm Tech/educ
- Study coordinator: Suryanarayanan, Raj
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 below.