CDER’s Product Quality Review of Biologics & Biosimilars: Common Findings, Review Issues and Post-Marketing Recommendations

Wednesday, September 18, 2024

1:00 PM - 2:00 PM PDT

Location/Room: 202

Presenter(s)

Kelly Nolan, MS

Senior Manager, Regulatory Affairs
Visterra, Inc
William Tubbs

Vice President and Head of Regulatory Affairs
Visterra, Inc
Tulay Kilicdagi, MA, RAC-Drugs

Associate Director, Regulatory Affairs
Visterra, Inc

Slides

Presenter (Remote)(s)

Leslie A. Rivera Rosado, PhD

Supervisor
FDA / CDER / OPQ / OPQAIII

Slides

Description: In this session, we will present the underlying results from our analysis of product quality review packages of biologics and biosimilars approved by CDER in the last 3 years. This will include common CMC findings, review issues, role of CMC in Complete Response Letters (CRL) and post-marketing requirements/commitments. For small biotech companies working towards their first product approval, a survey of FDA (CDER) reviews of recent marketing applications can provide critical information on agency requirements and presentation of Module 3 information. The review will identify common post-marketing changes, FDA’s priorities and focus areas, necessary waivers, and other critical information for preparing a Biologics License Application (BLA) CMC module. This session will provide real world information to regulatory professionals to help guide their teams in producing a BLA CMC module, and potentially shortening the approval timeline.

Learning Objectives:

Upon completion of this session, participants should be able to list common post-marketing requirements and CMC related reasons for a Complete Response Letter
Upon completion of this session, participants will have a better understanding of FDA requested ways for presenting CMC information in BLA.
Upon completion of this session, participants will acquire practical information that may improve BLA module 3 submissions and an understanding of the impact on the submission and review process for Module 3.