Biologics Price Competition and Innovation Act: Striking a Delicate Balance between Innovation and Accessibility
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Biologics Price Competition and Innovation Act:
Striking a Delicate Balance Between Innovation
and Accessibility
Ude Lu*
The Biologics Price Competition and Innovation Act of
2009 (BPCIA, also known as the Biosimilar Act) was signed
into law in 2010 by President Barack Obama as part of the
healthcare reform bill.1 The central mission of the BPCIA is
two-fold: (1) providing sufficient incentives for continuous
innovations in biologic therapies (i.e., promoting innovation);
and (2) lowering the price of biologic therapies (i.e., promoting
accessibility).2 To promote innovation, the BPCIA provides
twelve-year Food and Drug Administration (FDA) exclusivity to
innovator biologics.3 This twelve-year FDA exclusivity prevents
generic biologics, also known as follow-on biologics (FOBs),
C 2014 Ude Lu
* JD Candidate, University of Minnesota Law School, 2014; PhD,
Biomedical Engineering, University of Southern California, 2011. I am deeply
indebted to Professor Thomas F. Cotter for providing me with invaluable
advice throughout the writing process. I sincerely thank Brian R. Dorn, PhD,
JD, for giving me inspiring opinions on the subject matter. I am grateful to my
MJLST colleagues Caroline Marsili, Brandon Palmen, Elliot Ferrell, Chris
Evans, and Nihal Parkar for their excellent comments and generous
assistance. I also thank my lovely wife for her patience and support. The
opinions expressed in this article represent my own and not those of my
current or future employers.
1. Biologics Price Competition and Innovation Act of 2009, Pub. L. No.
111-148, § 7001, 124 Stat. 119, 804 (2010). The Biologics Price Competition
and Innovation Act (BPCIA) was enacted as part of the Patient Protection and
Affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119, 804 (2010).
2. Biologics Price Competition and Innovation Act § 7001(b), 124 Stat. at
804 (It is the sense of the Senate that a biosimilars pathway balancing
innovations and consumer interests [i.e., accessibility] should be
established.).
3. Id. § 7002(k)(2)(A), 124 Stat. at 805.
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Biologics Price Competition and Innovation Act: Striking a Delicate Balance between Innovation and Accessibility
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