Interview: Stephen Kozlowski, MD, the director of the Office of Biotechnology Products (OBP) in the Office of Pharmaceutical Science, in the FDA?s Center for Drug Evaluation and Research.

Listen to BioPharm International?s Editor-in-Chief Laura Bush interview Stephen Kozlowski on the challenges of regulating biotech therapeutics.

This is part two of a two part podcast. In this podcast, Dr. Kozlowski addresses the regulation of follow-on biologics, the interchangeability of biosimilars, concerns about protein aggregation, FDA’s view on disposables, and how pharmacogenomics will affect quality control.