Review the statutory definitions of a biological product as well as distinctions that drive jurisdiction and regulatory pathway. Discuss pathways to market and how to determine which pathway to choose. Review of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Examine market exclusivities and intellectual property.
Kellie B. Combs, Partner, Ropes & Gray LLP
This session was recorded as part of FDLI's Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in March 2021.