Analyzing innovator and biosimilar products for better patient access
Systematic Analytical Characterization of Innovator and Biosimilar Products with the Focus on Post-translational Modifications
This study is looking at how certain changes in biologic medicines and their cheaper versions, called biosimilars, can affect how well they work and how safe they are, with the goal of making these affordable options better for patients.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Michigan at Ann Arbor NIH-funded |
| Lab location | 1 site (Ann Arbor, United States) |
| Project ID | NIH-10619672 on NIH RePORTER |
What this research studies
This research focuses on the systematic analysis of innovator biologics and their biosimilar counterparts, particularly examining post-translational modifications that can affect their efficacy and safety. By understanding these differences, the research aims to enhance the quality and accessibility of biosimilars, which are designed to be more affordable alternatives to expensive biologic therapies. The study will involve detailed analytical techniques to characterize these products, ultimately aiming to support regulatory decisions and improve patient outcomes.
Who could benefit from this research
Good fit: Ideal candidates for this research are patients who require biologic therapies and may benefit from more cost-effective biosimilar options.
Not a fit: Patients who do not require biologic therapies or are not eligible for biosimilars may not receive any benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to increased availability and affordability of biologic treatments for patients.
How similar studies have performed: Previous research has shown success in the development and approval of biosimilars, indicating a promising future for similar analytical approaches.
Where this research is happening
Ann Arbor, United States
- University of Michigan at Ann Arbor — Ann Arbor, United States (Active)
Researchers
- Principal investigator: Schwendeman, Anna — University of Michigan at Ann Arbor
- Study coordinator: Schwendeman, Anna
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.