Learning Tracks

FDA Expectations for Biosimilar Manufacturing Inspections

Tuesday, October 3, 2023

11:00 a.m. - 12:00 p.m.

Like small molecule products, the manufacturing inspection of a facility is integral when considering the quality of a biosimilar prior to approval. The process used to manufacture biosimilars is complex and the requirements to validate the process are significant. This session will outline FDA’s manufacturing expectations as applicants are developing their product, during the process leading up to the inspection, and during the inspection itself.

FDA speakers will elaborate on topics such as:

  • What to expect in preparing for an inspection
  • The rigorous process FDA goes through in scheduling and preparing for an inspection
  • What to expect during the actual inspection
  • How the process is tied into the application assessment and the impact of the inspectional observations on the FDA decision


Shawn Allwein, PhD
Vice President, Biologics CMC, Teva Pharmaceuticals

Michael Cutter, PhD
Chief Quality Officer, Biocon Biologics Ltd.

Chris Downey, PhD
Division Director, Division of Biotechnology Manufacturing, OPMA, OPQ, CDER, FDA

Sarah Brown, PharmD

Associate Director, Reg Strategy & Science RA Biosimilars, Sandoz