On This Page
Date: January 22, 2025 Time: 1:00 p.m. – 3:00 p.m. ET
| Topic & Presentations | Speakers |
|---|---|
| BsUFA III Regulatory Science Pilot Program: Progress Update | |
| BsUFA Program Introduction & Recap from Last Engagement | Darlese Solorzano, MS, MBA Senior Program Manager BsUFA Regulatory Science Pilot Program Office of Biotechnology Products (OBP) Office of Pharmaceutical Quality (OPQ) | CDER | FDA |
| Biosimilar User Fee Act (BsUFA) Regulatory Science Accelerator | Susan Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA |
| Updates on the BsUFA Program Research Portfolio | Kimberly Maxfield, PhD Scientific Lead BsUFA Regulatory Science Pilot Program Office of Therapeutic Biologics and Biosimilars (OTBB) Office of New Drugs (OND) | CDER | FDA |
| Landscape Assessment of Biosimilar Submissions | Jeffry Florian, PhD Associate Director Division of Applied Regulatory Science (DARS) Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) | CDER | FDA |
| Alternate Methods for Immunogenicity Assessment of Biosimilar Drug Products | Kristina Howard, DVM, PhD Research Veterinary Medical Officer DARS | OCP | OTS | CDER | FDA |
| Pilot Program Next Steps | Kimberly Maxfield |
| Interim Report Out with Poll Questions | Darlese Solorzano |
| Q&A Discussion Panel |
All speakers above and Sarah Yim, MD Emanuela Lacana, PhD |
| Closing Remarks | Darlese Solorzano |
Visit CDER Small Business and Industry Assistance Page
ABOUT THIS EVENT (Hosted by CDER SBIA)
The U.S. Food and Drug Administration (FDA) Biosimilar User Fee Act (BsUFA) III Regulatory Science Pilot program is hosting its second virtual event.
The agenda includes a recap of the activities of this regulatory science pilot program from the last engagement that occurred on October 16, 2023. Additionally, the webinar will include a status update on the program’s current research portfolio as it relates to the BsUFA III commitments as well as presentations and panel discussions by FDA staff. Lastly, FDA staff will present the next steps planned for the BsUFA III regulatory science program.
INTENDED AUDIENCE
- Regulatory science and regulatory affairs professionals working on scientific, public health, or policy issues related to biosimilar biological products or who submit Biologics License Applications (BLAs) under the abbreviated 351(k) licensure pathway
- Biosimilar product developers
- Researchers working on methodologies to advance biosimilar development
- Foreign regulators working in biosimilar and interchangeable product regulation
- Pharmacists and clinicians
- Patients or patient advocacy groups
- Biological product manufacturers
- Representatives from consortia or other organizations interested in improving access to biological products
TOPICS
- BsUFA III regulatory science pilot program overview and status
- BsUFA III regulatory science pilot program project vignettes
- Updates to the BsUFA III regulatory science pilot program next steps
- Stakeholder feedback and discussion on the BsUFA III regulatory science pilot program next steps and ongoing projects
FDA RESOURCES
-
Content current as of:
06/03/2025
