II 

118TH CONGRESS 

2D SESSION S. 5459 

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 SENATE OF THE UNITED STATES 

DECEMBER 9, 2024 

Mrs. BLACKBURN introduced the following bill; which was read twice and 

referred to the Committee on Finance 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Biosimilars Access and 

5 Affordability Act’’. 

6 SEC. 2. CHANGE OF WHEN BIOSIMILARS ARE ELIGIBLE FOR 

7 PRICE NEGOTIATIONS. 

8 (a) IN GENERAL.—Section 1192 of the Social Secu9 rity Act (42 U.S.C. 1320f–1) is amended— 


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1 (1) in subsection (c)— 

2 (A) in paragraph (1), in the matter before 

3 subparagraph (A), by striking ‘‘beginning be4 fore the first year that begins at least 9 months 

5 after the date on which’’ and inserting ‘‘during 

6 the price applicability period, except that a drug 

7 shall no longer be a selected drug for a par8 ticular year if, before the first day of such 

9 year,’’; 

10 (B) in paragraph (2)— 

11 (i) in subparagraph (b), by inserting 

12 ‘‘or after the end of such negotiation pe13 riod but before the first day of the initial 

14 price applicability year’’ after ‘‘such initial 

15 price applicability year’’; and 

16 (ii) in the flush matter following sub17 paragraph (B), by inserting ‘‘or any future 

18 publication of the maximum fair price 

19 under section 1195 or any application of 

20 such price’’ after ‘‘such negotiation pe21 riod’’; 

22 (2) in subsection (f)— 

23 (A) in paragraph (1)— 

24 (i) in subparagraph (A)— 


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1 (I) by striking ‘‘an extended mo2 nopoly drug (as defined in section 

3 1194(c)(4)’’; and 

4 (II) by striking ‘‘before the date’’ 

5 and inserting ‘‘on or before December 

6 31 of the year’’; 

7 (ii) in subparagraph (B)— 

8 (I) in the heading, by striking 

9 ‘‘REQUEST REQUIRED’’ and inserting 

10 ‘‘PROCEDURES’’; 

11 (II) by redesignating clauses (i) 

12 and (ii) as clauses (ii) and (iii) respec13 tively; 

14 (III) by inserting before clause 

15 (ii) (as so redesignated) the following: 

16 ‘‘(i) AUTOMATIC DELAY.—The Sec17 retary shall apply, with respect to a bio18 logical product described in subparagraph 

19 (A), the rules described in subparagraph 

20 (A) of paragraph (2) (subject to subpara21 graphs (B) and (C) of such paragraph) if, 

22 prior to the selected drug publication date 

23 for the list published under subsection (a) 

24 with respect to the initial price applica25 bility year for which the biological product 


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1 may have been included as a selected drug 

2 on such list but for paragraph (2)(A), the 

3 manufacturer of a biosimilar biological 

4 product for which such biological product 

5 will be the reference product has publicly 

6 disclosed in a press release or other com7 munication, or the Secretary determines 

8 from information from any other source— 

9 ‘‘(I) that such manufacturer’s 

10 application for licensure under section 

11 351(k) of the Public Health Service 

12 Act for the biosimilar biological prod13 uct was accepted for review or ap14 proved by the Food and Drug Admin15 istration; 

16 ‘‘(II) that such manufacturer’s 

17 clinical study of the biosimilar biologi18 cal product as described in section 

19 351(k)(2)(A)(i)(I)(cc) of the Public 

20 Health Service Act was initiated and 

21 remains ongoing; or 

22 ‘‘(III) such manufacturer expects 

23 that the biosimilar biological product 

24 will be marketed on or before Decem25 ber 31 of the year that is 2 years 


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1 after the selected drug publication 

2 date with respect to such initial price 

3 applicability year.’’; 

4 (IV) in clause (ii) (as so redesig5 nated)— 

6 (aa) by striking subclause 

7 (II); 

8 (bb) by striking ‘‘IN GEN9 ERAL’’ and all that follows 

10 through ‘‘unless’’ and inserting 

11 ‘‘DELAY UPON REQUEST.— The 

12 Secretary shall provide for a 

13 delay under paragraph (2)(A) 

14 if’’; and 

15 (cc) by striking ‘‘subpara16 graph (2)(A) or;’’ and inserting 

17 ‘‘paragraph (2)(A), provided that 

18 a determination of high likelihood 

19 is made under paragraph (3).’’; 

20 and 

21 (V) in clause (iii) (as so redesig22 nated)— 

23 (aa) in the heading, by in24 serting ‘‘FOR A DELAY UPON RE25 QUEST’’ after ‘‘DOCUMENTS’’; 


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1 (bb) in subclause (I), in the 

2 matter before item (aa), by strik3 ing ‘‘clause (i)’’ and inserting 

4 ‘‘clause (ii)’’; and 

5 (cc) in subclause (III)(bb), 

6 by striking ‘‘year (or the 2 years, 

7 as applicable)’’ and inserting 

8 ‘‘applicable period’’; and 

9 (iii) in subparagraph (C)(i), by strik10 ing ‘‘paragraph (2)(D)(iv)’’ and inserting 

11 ‘‘paragraph (2)(C)(iii)’’; 

12 (B) in paragraph (2)— 

13 (i) in subparagraph (A)— 

14 (I) in the heading, by striking ‘‘1

15 YEAR’’ and inserting ‘‘2 YEARS’’; 

16 (II) by inserting ‘‘or paragraph 

17 (1)(B)(i) applies’’ after ‘‘under para18 graph (3)’’; and 

19 (III) by striking ‘‘1 year’’ and in20 serting ‘‘2 years’’; 

21 (ii) by striking subparagraph (B) and 

22 inserting the following: 

23 ‘‘(B) IF NOT LICENSED AND MARKETED

24 DURING THE DELAY.—If, during the time pe25 riod between the selected drug publication date 


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1 on which the biological product would have been 

2 included on the list as a selected drug pursuant 

3 to subsection (a) but for subparagraph (A), and 

4 the selected drug publication date with respect 

5 to the initial price applicability year that is 2 

6 years after the initial price applicability year for 

7 which such biological product would have been 

8 included as a selected drug on such list, the 

9 Secretary determines that the biosimilar biologi10 cal product for which the manufacturer sub11 mitted the request under paragraph (1)(B)(ii) 

12 (and for which the Secretary previously made a 

13 high likelihood determination under paragraph 

14 (3)) has not been licensed and marketed under 

15 section 351(k) of the Public Health Service 

16 Act— 

17 ‘‘(i) the Secretary shall include the bi18 ological product as a selected drug on the 

19 list published under subsection (a) with re20 spect to the initial price applicability year 

21 that is 2 years after the initial price appli22 cability year for which such biological 

23 product would have been included as a se24 lected drug on such list but for subpara25 graph (A); and 


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1 ‘‘(ii) if such biosimilar biological prod2 uct has not been licensed and marketed 

3 under section 351(k) of the Public Health 

4 Service Act on or before December 31 of 

5 the year that is 2 years after the selected 

6 drug publication date on which the biologi7 cal product would have been included on 

8 the list as a selected drug pursuant to sub9 section (a) but for subparagraph (A), the 

10 manufacturer of such biological product 

11 shall pay a rebate under paragraph (4) 

12 with respect to the years for which such 

13 manufacturer would have provided access 

14 to a maximum fair price for such biological 

15 product but for subparagraph (A).’’; 

16 (iii) by striking subparagraph (C); 

17 (iv) by redesignating subparagraph 

18 (D) as subparagraph (C); and 

19 (v) in subparagraph (C) (as so redes20 ignated)— 

21 (I) by striking clause (ii); 

22 (II) by redesignating clauses (iii) 

23 and (iv) as clauses (ii) and (iii), re24 spectively; 


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1 (III) in clause (ii) (as so redesig2 nated)— 

3 (aa) in the heading, by 

4 striking ‘‘1 YEAR’’ and inserting 

5 ‘‘2 YEARS’’; and 

6 (bb) by striking ‘‘1 year 

7 has’’ and inserting ‘‘2 years 

8 have’’; and 

9 (IV) in clause (iii)(II) (as so re10 designated), by striking ‘‘paragraph 

11 (1)(B)(ii)(I)(bb)’’ and inserting 

12 ‘‘paragraph (1)(B)(iii)(I)(bb)’’; 

13 (C) by striking paragraph (3) and insert14 ing the following: 

15 ‘‘(3) HIGH LIKELIHOOD.—For purposes of this 

16 subsection, there is a high likelihood described in 

17 paragraph (1) or paragraph (2), as applicable, if the 

18 Secretary finds that information from items de19 scribed in subclauses (I)(bb) and (III) of paragraph 

20 (1)(B)(iii) submitted to the Secretary by the manu21 facturer requesting a delay under such paragraph or 

22 information submitted to the Secretary by any other 

23 party or otherwise available to the Secretary from 

24 any other source provides clear and convincing evi25 dence that such biosimilar biological product will, 


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1 within the time period specified under paragraph 

2 (1)(A) be marketed.’’; and 

3 (D) in paragraph (4)— 

4 (i) in subparagraph (A)— 

5 (I) by striking ‘‘subparagraphs 

6 (B)(ii)(II) and (C)(ii) of paragraph 

7 (2)’’ and inserting ‘‘paragraph 

8 (2)(B)(ii)’’; and 

9 (II) by inserting ‘‘not earlier 

10 than January 1 of the year that is 3 

11 years after the selected drug publica12 tion date of the list on which the bio13 logical product would have been in14 cluded as a selected drug but for a 

15 delay under paragraph (2)(A)’’ after 

16 ‘‘at such time’’; and 

17 (ii) in subparagraph (B)— 

18 (I) in clause (i), by striking sub19 clause (I) and inserting the following: 

20 ‘‘(I) 75 percent of the amount by 

21 which the average manufacturer price, 

22 as reported by the manufacturer of 

23 such covered part D drug under sec24 tion 1927 (or, if not reported by such 

25 manufacturer under section 1927, as 


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1 reported by such manufacturer to the 

2 Secretary pursuant to the agreement 

3 under section 1193(a)) for such bio4 logical product, with respect to each 

5 of the calendar quarters of the price 

6 applicability period that would have 

7 applied but for this subsection; ex8 ceeds— 

9 ‘‘(aa) for the initial price ap10 plicability year that would have 

11 applied but for a delay under 

12 paragraph (2)(A), the maximum 

13 fair price negotiated under sec14 tion 1194 for such biological 

15 product under such agreement; 

16 or 

17 ‘‘(bb) for the second year of 

18 such delay and the remaining pe19 riod of such delay ending on De20 cember 31 of the year that is 2 

21 years after the selected drug pub22 lication date of the list on which 

23 the biological product would have 

24 been included as a selected drug 

25 but for a delay under paragraph 


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1 (2)(A), such maximum fair price, 

2 increased as described in section 

3 1195(b)(1)(A); and’’; and 

4 (II) in clause (ii), by striking 

5 subclause (I) and inserting the fol6 lowing: 

7 ‘‘(I) 80 percent of the amount by 

8 which the payment amount for such 

9 biological product under section 

10 1847A(b), with respect to each of the 

11 calendar quarters of the price applica12 bility period that would have applied 

13 but for this subsection; exceeds— 

14 ‘‘(aa) for the initial price ap15 plicability year that would have 

16 applied but for a delay under 

17 paragraph (2)(A), the maximum 

18 fair price negotiated under sec19 tion 1194 for such biological 

20 product under such agreement; 

21 or 

22 ‘‘(bb) for the second year of 

23 such delay and the remaining pe24 riod of such delay ending on De25 cember 31 of the year that is 2 


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1 years after the selected drug pub2 lication date of the list on which 

3 the biological product would have 

4 been included as a selected drug 

5 but for a delay under paragraph 

6 (2)(A), such maximum fair price, 

7 increased as described in section 

8 1195(b)(1)(A); and’’; and 

9 (3) by adding at the end the following new sub10 section: 

11 ‘‘(g) DEFINITION OF MARKET.—In this section, the 

12 term ‘market’ means to introduce or deliver a drug or bio13 logical product (including a biosimilar biological product) 

14 for introduction into interstate commerce.’’. 

15 (b) CONFORMING AND TECHNICAL AMENDMENTS.— 

16 Such Act is amended— 

17 (1) in section 1192(b)(3) (42 U.S.C. 1320f– 

18 1(b)(3)), by striking ‘‘subparagraphs (B)(ii)(I) and 

19 (C)(i) of subsection (f)(2)’’ and inserting ‘‘subsection 

20 (f)(2)(B)(ii)’’; and 

21 (2) in section 1198(2) (42 U.S.C. 1320f–7(2)), 

22 by striking ‘‘1192(f),’’ and inserting ‘‘1192(f)’’. 

23 (c) EFFECTIVE DATE.—The amendments made by 

24 this section shall apply with respect to initial price applicaVerDate Sep 11 2014 18:43 Jan 02, 2025 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S5459.IS S5459

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1 bility years beginning with initial price applicability year 

2 2027. 

Æ 


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