[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6155 Introduced in House (IH)]
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116th CONGRESS
2d Session
H. R. 6155
To amend the Biologics Price Competition and Innovation Act of 2009 to
make improvements with respect to the transition of biological
products, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 9, 2020
Mr. Grothman introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Biologics Price Competition and Innovation Act of 2009 to
make improvements with respect to the transition of biological
products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. STREAMLINING THE TRANSITION OF BIOLOGICAL PRODUCTS.
(a) Continued Review of Certain Applications.--Section
7002(e)(4)(B) of the Biologics Price Competition and Innovation Act of
2009 (Public Law 111-148) is amended--
(1) by striking clauses (i), (ii), and (vi); and
(2) by inserting before clause (iii) the following:
``(i) In general.--With respect to an
application for a biological product submitted
under subsection (b) or (j) of section 505 of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) that is filed not later than March
23, 2019, and that is pending (or tentatively
approved) as of March 23, 2020--
``(I) the Secretary shall continue
to review such application under such
section 505, even if such review
continues after March 23, 2020; and
``(II) upon approval of such
application, such application shall be
deemed to be a license for the
biological product under section 351 of
the Public Health Service Act, pursuant
to subparagraph (A), and any period of
exclusivity, as applicable, shall be
determined in accordance with such
section.
``(ii) Treatment of listed drugs.--With
respect to a drug that is a biological product
that has been deemed licensed under section 351
of the Public Health Service Act (42 U.S.C.
262) pursuant to subparagraph (A) and that is
referenced in an application described in
clause (i), such drug shall--
``(I) continue to be identified as
a listed drug on the list published
pursuant to section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act,
and the information for such drug on
such list shall not be revised (or
removed) unless and until the date on
which each application described in
clause (i) that references such drug
is--
``(aa) no longer pending
review (or the approval of such
drug is tentative) under
section 505 of the Federal
Food, Drug, and Cosmetic Act
(21 U.S.C. 355); or
``(bb) removed from such
list in accordance with
subparagraph (C) of such
section 505(j)(7);
``(II) be subject only to
requirements applicable to biological
products licensed under section 351 of
the Public Health Service Act (42
U.S.C. 262); and
``(III) be deemed to be a reference
product under such section 351 on the
date on which the last application
described in clause (i) that references
such drug is no longer pending review
(or tentatively approved) under section
505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355).''.
(b) Certain Insulin Products Deemed Interchangeable Biosimilars.--
Section 7002(e)(4) of the Biologics Price Competition and Innovation
Act of 2009 (Public Law 111-148) is amended by adding at the end the
following:
``(C) Certain insulin products deemed
interchangeable biosimilars.--
``(i) In general.--In carrying out
subparagraph (A), a covered insulin product
shall be deemed to be an interchangeable
biosimilar biological product licensed under
section 351(k) of the Public Health Service
Act.
``(ii) Definitions.--In this subparagraph:
``(I) The terms `biosimilar' and
`interchangeable' have the meaning
given such terms in section 351(i) of
the Public Health Service Act.
``(II) The term `covered insulin
product' means a biological product
(including a chemically synthesized
polypeptide) that is--
``(aa) an insulin product;
and
``(bb) approved under
section 505 of the Federal
Food, Drug, and Cosmetic Act
pursuant to an application
submitted under subsection
(b)(2) of such section.''.
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