The Follow-On Biologics Market: Enter at Your Own Risk

18 Pages Posted: 8 Dec 2011

See all articles by Anjan Chatterji

Anjan Chatterji

affiliation not provided to SSRN

R. Terry Hisey

affiliation not provided to SSRN

Rob Jacoby

affiliation not provided to SSRN

Ted Hoffman

affiliation not provided to SSRN

Date Written: December 8, 2011

Abstract

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

Chatterji, Anjan and Hisey, R. Terry and Jacoby, Rob and Hoffman, Ted, The Follow-On Biologics Market: Enter at Your Own Risk (December 8, 2011). Available at SSRN: https://ssrn.com/abstract=1969973 or http://dx.doi.org/10.2139/ssrn.1969973

Anjan Chatterji (Contact Author)

affiliation not provided to SSRN

R. Terry Hisey

affiliation not provided to SSRN

Rob Jacoby

affiliation not provided to SSRN

Ted Hoffman

affiliation not provided to SSRN

Register to save articles to
your library

Register

Paper statistics

Downloads
126
Abstract Views
774
rank
231,581
PlumX Metrics