Biosimilars Access and Affordability Act

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 before subparagraph (A), by striking beginning before the first year that begins at least 9 months after the date on which and inserting during the price applicability period, except that a drug shall no longer be a selected drug for a particular year if, before the first day of such year,;

(B) in paragraph (2)—

(i) in subparagraph (b), by inserting or after the end of such negotiation period but before the first day of the initial price applicability year after such initial price applicability year; and

(ii) in the flush matter following subparagraph (B), by inserting or any future publication of the maximum fair price under section 1195 or any application of such price after such negotiation period;

(2) in subsection (f)—

(A) in paragraph (1)—

(i) in subparagraph (A)—

(I) by striking an extended monopoly drug (as defined in section 1194(c)(4); and

(II) by striking before the date and inserting on or before December 31 of the year;

(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:

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), 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—

(I) 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;

(II) that such manufacturer’s clinical study of the biosimilar biological product as described in section 351(k)(2)(A)(i)(I)(cc) of the Public Health Service Act was initiated and remains ongoing; or

(III) such manufacturer expects that the biosimilar biological product will be marketed on or before December 31 of the year that is 2 years after the selected drug publication date with respect to such initial price applicability year.

(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); and

(cc) in subclause (III)(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:

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 the biosimilar biological product for which the manufacturer submitted the request under paragraph (1)(B)(ii) (and for which the Secretary previously made a high likelihood determination under paragraph (3)) has not 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 December 31 of the year 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 clause (ii);

(II) by redesignating clauses (iii) and (iv) as clauses (ii) and (iii), respectively;

(III) in clause (ii) (as so redesignated)—

(aa) in the heading, by striking 1 year and inserting 2 years; and

(bb) by striking 1 year has and inserting 2 years have; and

(IV) in clause (iii)(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:

For purposes of this subsection, there is a high likelihood described in paragraph (1) or paragraph (2), as applicable, if the Secretary finds that information from items described in subclauses (I)(bb) and (III) of paragraph (1)(B)(iii) submitted to the Secretary by the manufacturer requesting a delay under such paragraph or information submitted to the Secretary by any other party or otherwise available to 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.

(C) ; and

(D) in paragraph (4)—

(i) in subparagraph (A)—

(I) by striking subparagraphs (B)(ii)(II) and (C)(ii) of paragraph (2) and inserting paragraph (2)(B)(ii); and

(II) by inserting not earlier than January 1 of the year that is 3 years after the selected drug publication date of the list on which the biological product would have been included as a selected drug but for a delay under paragraph (2)(A) after at such time; 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 and the remaining period of such delay ending on December 31 of the year that is 2 years after the selected drug publication date of the list on which the biological product would have been included as a selected drug but for a delay under paragraph (2)(A), such maximum fair price, increased as described in section 1195(b)(1)(A); and

(I) ; 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 and the remaining period of such delay ending on December 31 of the year that is 2 years after the selected drug publication date of the list on which the biological product would have been included as a selected drug but for a delay under paragraph (2)(A), such maximum fair price, increased as described in section 1195(b)(1)(A); and

(II) ; and

(3) by adding at the end the following new subsection:

In this section, the term market means to introduce or deliver a drug or biological product (including a biosimilar biological product) for introduction into interstate commerce.

Such Act is amended—

(1) in section 1192(b)(3) (42 U.S.C. 1320f–1(b)(3)), by striking subparagraphs (B)(ii)(I) and (C)(i) of subsection (f)(2) and inserting subsection (f)(2)(B)(ii); and

(2) in section 1198(2) (42 U.S.C. 1320f–7(2)), by striking 1192(f), and inserting 1192(f).

The amendments made by this section shall apply with respect to initial price applicability years beginning with initial price applicability year 2027.