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I
116TH CONGRESS
2D SESSION
H. R. 8190
To amend the Public Health Service Act to deem any insulin that is deter-
mined by the Secretary to be biosimilar to the reference product to
be interchangeable with the reference product, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 8, 2020
Mr. GROTHMAN introduced the following bill; which was referred to the
Committee on Energy and Commerce
A BILL
To amend the Public Health Service Act to deem any insulin
that is determined by the Secretary to be biosimilar
to the reference product to be interchangeable with the
reference product, and for other purposes.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Biosimilar Insulin Ac-
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cess Act of 2020’’.
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SEC. 2. DEEMING BIOSIMILAR INSULIN TO BE INTER-
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CHANGEABLE.
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(a) IN GENERAL.—Section 351(k)(3) of the Public
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Health Service Act (42 U.S.C. 262(k)(3)) is amended by
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adding at the end the following:
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‘‘(B) BIOSIMILAR INSULIN.—
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‘‘(i) DEEMED
INTERCHANGEABLE.—
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Notwithstanding paragraph (4), an insulin
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is deemed to be interchangeable with the
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reference product if the insulin is deter-
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mined by the Secretary to be biosimilar to
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the reference product.
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‘‘(ii) SHORTENING EXCLUSIVITY FOR
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FIRST INTERCHANGEABLE PRODUCT.—
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‘‘(I) ACTION INSTITUTED.—If an
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action is instituted under subsection
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(l)(6) against the applicant that sub-
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mitted the application for an insulin
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that is the first approved interchange-
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able biosimilar biological product,
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paragraph (6) shall apply with respect
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to such insulin without regard to
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paragraph (6)(A).
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‘‘(II)
ACTION
NOT
INSTI-
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TUTED.—If such an action is not in-
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stituted with respect to an insulin
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•HR 8190 IH
that is approved as an interchangeable
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biosimilar biological product, the Sec-
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retary shall make a determination on
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the interchangeability of any second
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or subsequent biological product with-
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out regard to the delay otherwise re-
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quired by paragraph (6).
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‘‘(iii) APPLICABILITY.—Clause (i) ap-
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plies without regard to whether the insulin
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is determined to be biosimilar to the ref-
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erence product, or deemed to be licensed
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pursuant to this section, before or after the
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date of enactment of the Biosimilar Insulin
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Access Act of 2020.’’.
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(b) CONFORMING CHANGES.—Section 351(k)(3) of
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the Public Health Service Act (42 U.S.C. 262(k)(3)) is
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amended—
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(1) by striking ‘‘Upon review’’ and inserting the
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following:
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‘‘(A) IN GENERAL.—Upon review’’;
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(2) by striking ‘‘(A) the Secretary’’ and insert-
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ing the following:
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‘‘(i) the Secretary’’;
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(3) by striking ‘‘(i) is biosimilar’’ and inserting
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the following:
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‘‘(I) is biosimilar’’;
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(4) by striking ‘‘(ii) can be’’ and inserting the
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following:
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‘‘(II) can be’’; and
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(5) by striking ‘‘(B) the applicant’’ and insert-
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ing the following:
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‘‘(ii) the applicant’’.
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Æ
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