[Ip-health] 12 Years Data Exclusivity in US Compromise Legislation for Biogenerics/Biosimilars

[Mike Palmedo]

This is from compromise language for a bill to permit the approval of
generic biologics, or biosimilars.  The bill includes 12 years of data
exclusivity.  Some clinical trials would be required for generic
approval, though the FDA could waive the requirement on a case-by-case
basis.

Full text of the legislation, which would give biologics 12 years of
data exclusivity:
http://www.biologicdrugreport.com/News/Docs/compromise-0607.pdf

[snip]

(7) EXCLUSIVITY FOR REFERENCE PRODUCT -

(A)  EFFECTIVE DATE OF BIOSIMILAR APPLICATION APPROVAL - Approval of an
application under this subsection may not be made effective by the
Secretary until the date that is 12 years after the date on which the
reference product was first licensed under subsection (a).

[snip]

--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu