II
116th CONGRESS
1st Session
S. 1140
IN THE SENATE OF THE UNITED STATES
April 11, 2019
Ms. Smith (for herself and Mr. Cassidy) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
A BILL
To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009.
Short title
This Act may be cited as the Protecting Access to Biosimilars Act of 2019
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Treatment of biological products deemed licensed
Section 351(k)(7) of the Public Health Service Act (42 U.S.C. 262(k)(7)) is amended by adding at the end the following:
Deemed licenses
No additional exclusivity through deeming
An approved application that is deemed to be a license for a biological product under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a) for purposes of subparagraphs (A) and (B).
Limitation on exclusivity applies to any reference product
Subparagraph (C) shall apply to any reference product, without regard to whether—
such product was first licensed under subsection (a); or
the approved application for such product was deemed to be a license for a biological product as described in clause (i).
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