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House Bill 2011
116th Congress(2019-2020)
Protecting Access to Biosimilars Act of 2019
Introduced
Introduced
Introduced in House on Apr 1, 2019
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Text
Introduced in House 
Apr 1, 2019
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Introduced in House(Apr 1, 2019)
Apr 1, 2019
About Linkage
Multiple bills can contain the same text. This could be an identical bill in the opposite chamber or a smaller bill with a section embedded in a larger bill.
Bill Sponsor regularly scans bill texts to find sections that are contained in other bill texts. When a matching section is found, the bills containing that section can be viewed by clicking "View Bills" within the bill text section.
Bill Sponsor is currently only finding exact word-for-word section matches. In a future release, partial matches will be included.
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H. R. 2011 (Introduced-in-House)


116th CONGRESS
1st Session
H. R. 2011


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 biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009.

IN THE HOUSE OF REPRESENTATIVES

April 1, 2019

Ms. DeGette (for herself, Mr. Reed, Ms. Schrier, and Mr. Guthrie) introduced the following bill; which was referred to the Committee on Energy and Commerce

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 biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. Short title.

This Act may be cited as the “Protecting Access to Biosimilars Act of 2019”.

SEC. 2. 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:

“(D) DEEMED LICENSES.—

“(i) 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).

“(ii) APPLICABILITY OF ANTIEVERGREENING PROVISIONS.—Subparagraph (C) shall apply to any reference product, without regard to whether—

“(I) such product was first licensed under subsection (a); or

“(II) the approved application for such product was deemed to be a license for a biological product as described in clause (i).”.