The Follow-On Biologics Market: Enter at Your Own Risk
18 Pages Posted: 8 Dec 2011
Date Written: December 8, 2011
With the passage of the Biologics Price Competition and Innovation Act as part of the 2010 Patient Protection and Affordable Care Act, it seems that the wait for follow-on biologics (FOB) is almost over; however, there is a growing concern amongst industry experts that non-incumbent entrants will face unique barriers that are absent in the small molecule generic market. However, given the proper resources and ability to adopt the winning strategies outlined in this paper, we believe the FOB market will eventually be an emerging and flouring market for interested investors.
Keywords: generics, follow-on biologics, biosimilars, interchangeablility, FDA, biologics, innovation, incumbent, BLA, NDA, Biologics Price Competition and Innovation Act, 2010 Patient Protection and Affordable Care Act, Data Exclusivity, patents
JEL Classification: K00
Suggested Citation: Suggested Citation