U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. BsUFA III Regulatory Science Pilot Program: Progress Update - 01/22/2025
  1. News & Events for Human Drugs

Virtual | Virtual

Event Title
BsUFA III Regulatory Science Pilot Program: Progress Update
January 22, 2025

Date:
January 22, 2025
Time:
1:00 p.m. - 3:00 p.m. ET

Topic & PresentationsSpeakers
BsUFA III Regulatory Science Pilot Program: Progress Update 
BsUFA Program Introduction & Recap from Last EngagementDarlese 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 AcceleratorSusan Winckler, RPh, Esq
Chief Executive Officer
Reagan-Udall Foundation for the FDA
Updates on the BsUFA Program Research PortfolioKimberly 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 SubmissionsJeffry 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 ProductsKristina Howard, DVM, PhD
Research Veterinary Medical Officer
DARS | OCP | OTS | CDER | FDA
Pilot Program Next StepsKimberly Maxfield
Interim Report Out with Poll QuestionsDarlese Solorzano
Q&A Discussion Panel

All speakers above

and

Sarah Yim, MD
Director
OTBB | OND |CDER | FDA

Emanuela Lacana, PhD
Deputy Director
OTBB |OND | CDER | FDA

Closing RemarksDarlese Solorzano

AGENDA

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

Back to Top