Learning Tracks

The Evolving Science of Interchangeability

Wednesday, October 4, 2023

10:00 a.m. - 11:30 a.m.

What have we learned about interchangeable biosimilars? In light of many biosimilars becoming available in 2023, including some that are interchangeable and others that are not, the panel will discuss interchangeable biosimilars, including insulin (Semglee/Lantus) and ranibizumab (Cimerli/Lucentis). Additionally, FDA will discuss the factors or characteristics that led to the agency waiving switching studies for some interchangeable biosimilars. Industry representatives will share their perspectives on developing products for multiple global regulatory agencies.

Speakers:

Hillel Cohen, PhD
Executive Director, Scientific Affairs, Sandoz Inc.

Stacey Ricci, M.Eng., Sc.D.
Director, Scientific Review Staff, OTBB, OND, CDER, FDA

Anupama Reddy, M.S.
Head, Quality Function Program Management Office, Biocon Biologics Limited

Thomas Herndon, M.D.
Scientific Review Staff, OTBB, OND, CDER, FDA