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H.R. 2011: Protecting Access to Biosimilars Act of 2019

The text of the bill below is as of Apr 1, 2019 (Introduced).


I

116th CONGRESS

1st Session

H. R. 2011

IN THE HOUSE OF REPRESENTATIVES

April 1, 2019

(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.

1.

Short title

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

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).

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