Learning Tracks

This session will examine regulatory and scientific considerations for generic and biosimilar drug-device combination products, including therapeutic equivalence, interchangeability, and the role of comparative use human factors studies. Using the GDUFA Regulatory Science project evaluating “other” design differences between semi-automated and manual injection pen platforms as a starting point, panelists will discuss the assumption of negative transfer, how device differences may or may not affect user performance, and how emerging evidence should inform FDA’s regulatory framework for generics and biosimilars that reference drug- and biologic-device combination products.

Cristina Ausin, PhD
Scientific Reviewer, OTBB, OND, CDER, FDA

Ariane Conrad, PharmD
Associate Director for Human Factors, DMEPAI, OMEPRM OSE, CDER, FDA

Aparna Dagar, PhD, RAC
Vice President Regulatory Affairs, Fresenius Kabi USA, LLC

Johannes Keuschinigg, PhD
Director, Regulatory Affairs Device, Sandoz

Markham Luke, M.D., PhD
Director, DTPI, ORS, OGD, CDER, FDA

Kim Witzmann, M.D.
Deputy Director, IO, OSCE, OGD, CDER, FDA