HouseH.R. 10628119th Congress
Biosimilars Access and Affordability Act
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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 10628 Introduced in House (IH)]
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119th CONGRESS
2d Session
H. R. 10628
To amend title XI of the Social Security Act to alter when biosimilar
biological products are eligible for price negotiations under the
Medicare program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 28, 2026
Mr. Langworthy (for himself, Mr. Auchincloss, Mr. Joyce of
Pennsylvania, Ms. Sanchez, Mr. Peters, Mr. Yakym, Mr. Moran, Mr.
Mullin, and Mr. Panetta) introduced the following bill; which was
referred to the Committee on Energy and Commerce, and in addition to
the Committee on Ways and Means, for a period to be subsequently
determined by the Speaker, in each case for consideration of such
provisions as fall within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend title XI of the Social Security Act to alter when biosimilar
biological products are eligible for price negotiations under the
Medicare program.
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 ``Biosimilars Access and Affordability
Act''.
SEC. 2. CHANGE OF WHEN BIOSIMILARS ARE ELIGIBLE FOR PRICE NEGOTIATIONS.
(a) In General.--Section 1192 of the Social Security Act (42 U.S.C.
1320f-1) is amended--
(1) in subsection (c)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``such year and each
subsequent year beginning before the first year that
begins at least 9 months'' and inserting ``the year of
the selected drug publication date for such initial
price applicability year and each subsequent year,
except that a drug or biological product shall no
longer be a selected drug beginning on the first day of
the year that begins''; and
(B) in paragraph (2)--
(i) in subparagraph (B), by striking ``or
during the negotiation period with respect to
such initial price applicability year'' and
inserting ``the first day of such initial price
applicability year''; and
(ii) in the flush text following
subparagraph (B)--
(I) by striking ``and shall
continue'' and inserting ``if such
negotiation period has not yet ended,
shall not have its maximum fair price
or the explanation of such maximum fair
price published under section 1195(a)
if such publication has not yet
occurred, and'';
(II) by inserting ``solely'' before
``with respect to the number''; and
(III) by inserting ``, but no
maximum fair price shall apply for such
initial price applicability year in
accordance with paragraph (1)'' before
the period at the end;
(2) in subsection (f)--
(A) in paragraph (1)--
(i) in subparagraph (A), by striking ``an
extended monopoly drug (as defined in section
1194(c)(4)'';
(ii) in subparagraph (B)--
(I) in the heading, by striking
``Request required'' and inserting
``Procedures'';
(II) by redesignating clauses (i)
and (ii) as clauses (ii) and (iii)
respectively;
(III) by inserting before clause
(ii) (as so redesignated) the
following:
``(i) Automatic delay.--
``(I) In general.--The Secretary
shall apply, with respect to a
biological product described in
subparagraph (A), the rules described
in subparagraph (A) of paragraph (2)
(subject to subparagraphs (B) and (C)
of such paragraph) if, prior to the
selected drug publication date for the
list published under subsection (a)
with respect to the initial price
applicability year for which the
biological product may have been
included as a selected drug on such
list but for paragraph (2)(A)--
``(aa) the manufacturer of
a biosimilar biological product
for which such biological
product will be the reference
product has publicly disclosed
in a press release or other
communication, or the Secretary
determines from information
from any other source--
``(AA) that such
manufacturer's
application for
licensure under section
351(k) of the Public
Health Service Act for
the biosimilar
biological product was
accepted for review or
approved by the Food
and Drug
Administration; or
``(BB) that such
manufacturer's clinical
study or studies of the
biosimilar biological
product as described in
section
351(k)(2)(A)(i)(I)(cc)
of the Public Health
Service Act were
initiated and remain
ongoing, are complete,
or that no such study
or studies are
necessary; and
``(bb) subject to subclause
(II), based on information
submitted to the Secretary by
any person or obtained by the
Secretary from any other
source, the Secretary
determines that the
manufacturer of the biosimilar
biological product expects that
such product will be marketed
before the date that is 2 years
after the selected drug
publication date with respect
to such initial price
applicability year.
``(II) Requirements.--
``(aa) In general.--Before
making the determination
described in subclause
(II)(bb), the Secretary shall--
``(AA) inform the
manufacturer of the
biosimilar biological
product of the
information on which
the Secretary intends
to rely in making such
determination; and
``(BB) require that
such manufacturer
confirms in writing,
under penalty of
perjury, the accuracy
of such information or
corrects any such
inaccurate information,
including its expected
marketing date.
``(bb) Clarification.--The
existence of pending or
prospective patent litigation
over a biosimilar biological
product shall not preclude
application of the rules
described in subparagraph (A)
of paragraph (2) (subject to
paragraphs (B) and (C) of such
paragraph).'';
(IV) in clause (ii) (as so
redesignated)--
(aa) by striking subclause
(II);
(bb) by striking ``In
general'' and all that follows
through ``unless'' and
inserting ``Delay upon
request.-- The Secretary shall
provide for a delay under
paragraph (2)(A) if''; and
(cc) by striking
``subparagraph (2)(A) or;'' and
inserting ``paragraph (2)(A),
provided that a determination
of high likelihood is made
under paragraph (3).''; and
(V) in clause (iii) (as so
redesignated)--
(aa) in the heading, by
inserting ``for a delay upon
request'' after ``documents'';
(bb) in subclause (I), in
the matter before item (aa), by
striking ``clause (i)'' and
inserting ``clause (ii)'';
(cc) in subclause (I)(bb),
by inserting ``to the extent
available,'' before ``all
agreements''; and
(dd) in subclause
(III)(bb)--
(AA) by inserting
``the anticipated
launch date'' before
``capital investment'';
and
(BB) by striking
``year (or the 2 years,
as applicable)'' and
inserting ``applicable
period''; and
(iii) in subparagraph (C)(i), by striking
``paragraph (2)(D)(iv)'' and inserting
``paragraph (2)(C)(iii)'';
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) in the heading, by striking ``1
year'' and inserting ``2 years'';
(II) by inserting ``or paragraph
(1)(B)(i) applies'' after ``under
paragraph (3)''; and
(III) by striking ``1 year'' and
inserting ``2 years'';
(ii) by striking subparagraph (B) and
inserting the following:
``(B) If not licensed and marketed during the
delay.--If, during the time period between the selected
drug publication date on which the biological product
would have been included on the list as a selected drug
pursuant to subsection (a) but for subparagraph (A),
and the selected drug publication date with respect to
the initial price applicability year that is 2 years
after the initial price applicability year for which
such biological product would have been included as a
selected drug on such list, the Secretary determines
that such biological product is not the reference
product for a biosimilar biological product that has
been licensed and marketed under section 351(k) of the
Public Health Service Act--
``(i) the Secretary shall include the
biological product as a selected drug on the
list published under subsection (a) with
respect to the initial price applicability year
that is 2 years after the initial price
applicability year for which such biological
product would have been included as a selected
drug on such list but for subparagraph (A); and
``(ii) if such biosimilar biological
product has not been licensed and marketed
under section 351(k) of the Public Health
Service Act on or before the date that is 2
years after the selected drug publication date
on which the biological product would have been
included on the list as a selected drug
pursuant to subsection (a) but for subparagraph
(A), the manufacturer of such biological
product shall pay a rebate under paragraph (4)
with respect to the years for which such
manufacturer would have provided access to a
maximum fair price for such biological product
but for subparagraph (A).'';
(iii) by striking subparagraph (C);
(iv) by redesignating subparagraph (D) as
subparagraph (C); and
(v) in subparagraph (C) (as so
redesignated)--
(I) by striking clauses (ii) and
(iii);
(II) by redesignating clause (iv)
as clause (ii); and
(III) in clause (ii)(II) (as so
redesignated), by striking ``paragraph
(1)(B)(ii)(I)(bb)'' and inserting
``paragraph (1)(B)(iii)(I)(bb)'';
(C) by striking paragraph (3) and inserting the
following:
``(3) High likelihood.--
``(A) In general.--Subject to subparagraph (B), for
purposes of this subsection, there is a high likelihood
described in paragraph (1) or paragraph (2), as
applicable, if the Secretary determines that
information submitted to the Secretary by any person or
obtained by the Secretary from any other source
provides clear and convincing evidence that such
biosimilar biological product will, within the time
period specified under paragraph (1)(A) be marketed.
``(B) Determination requirements.--Before
determining whether there is a high likelihood
described in paragraph (1) or paragraph (2), the
Secretary shall inform the manufacturer of the
biosimilar biological product of the information on
which the Secretary intends to rely in making such
determination and shall require that such manufacturer
confirms in writing, under penalty of perjury, the
accuracy of such information or correct any such
inaccurate information.
``(C) Clarification.--The existence of pending or
prospective patent litigation regarding the biosimilar
biological product shall not preclude a finding of high
likelihood under this paragraph.''; and
(D) in paragraph (4)--
(i) in subparagraph (A), by striking
``subparagraphs (B)(ii)(II) and (C)(ii) of
paragraph (2)'' and inserting ``paragraph
(2)(B)(ii)''; and
(ii) in subparagraph (B)--
(I) in clause (i), by striking
subclause (I) and inserting the
following:
``(I) 75 percent of the amount by
which the average manufacturer price,
as reported by the manufacturer of such
covered part D drug under section 1927
(or, if not reported by such
manufacturer under section 1927, as
reported by such manufacturer to the
Secretary pursuant to the agreement
under section 1193(a)) for such
biological product, with respect to
each of the calendar quarters of the
price applicability period that would
have applied but for this subsection;
exceeds--
``(aa) for the initial
price applicability year that
would have applied but for a
delay under paragraph (2)(A),
the maximum fair price
negotiated under section 1194
for such biological product
under such agreement; or
``(bb) for the second year
of such delay, such maximum
fair price, increased as
described in section
1195(b)(1)(A); and''; and
(II) in clause (ii), by striking
subclause (I) and inserting the
following:
``(I) 80 percent of the amount by
which the payment amount for such
biological product under section
1847A(b), with respect to each of the
calendar quarters of the price
applicability period that would have
applied but for this subsection;
exceeds--
``(aa) for the initial
price applicability year that
would have applied but for a
delay under paragraph (2)(A),
the maximum fair price
negotiated under section 1194
for such biological product
under such agreement; or
``(bb) for the second year
of such delay, such maximum
fair price, increased as
described in section
1195(b)(1)(A); and''; and
(3) by adding at the end the following new subsection:
``(g) Definition of Marketed.--In this section, the term `marketed'
means, with respect to a drug or biological product (including a
biosimilar biological product) introduced or delivered for introduction
into interstate commerce.''.
(b) Conforming and Technical Amendments.--Such Act is amended--
(1) in section 1192(b)(3) (42 U.S.C. 1320f-1(b)(3))--
(A) by striking ``subparagraphs (B)(ii)(I) and
(C)(i) of subsection (f)(2)'' and inserting
``subsection (f)(2)(B)(i)''; and
(B) by striking ``described in such subparagraphs''
and inserting ``described in such subsection''; and
(2) in section 1198(2) (42 U.S.C. 1320f-7(2)), by striking
``1192(f),'' and inserting ``1192(f)''.
(c) Effective Date.--The amendments made by this section shall
apply with respect to initial price applicability years beginning with
initial price applicability year 2027.
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