FDA Webinar on the Biosimilar Approval Process


The Food and Drug Administration hosted a webinar last week on the on Biosimilar Approval Process, and Looks Ahead to Interchangeability.
Dr. Leah Christl, associate director for therapeutic biologics, Center for Drug Evaluation and Research (CDER), FDA, and Sue Lim, MD, medical officer at the FDA’s Office of New Drugs, hosted the webinar to outline the framework for biosimilars as well as the development and approval process for these drugs.
Christl stated that as of Dec. 1, 60 programs are enrolled in the Biosimilar Product Development (BPD). CDER has also received meeting requests to discuss the development of biosimilars for 27 reference products, and 11 companies have publicly announced submission of 20 individual 351(k) Biologics License Applications (BLAs) to the FDA since December 1, 2017.
View Presentation: https://collaboration.fda.gov/p6nzbmzxao6/
Download Presentation Slides: Biosimilar Products (PDF – 875KB)

Become a Member

Whether you have an established practice, you’re fresh out of your fellowship, or you’re a hospital-based rheumatologist considering private practice, United Rheumatology offers the resources and services you need to advance your career and your clinic.

Name(Required)

Find a UR Rheumatologist Near Me

© 2023 United Rheumatology