II 118TH CONGRESS 1ST SESSION S. 1522 To require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable. IN THE SENATE OF THE UNITED STATES MAY 10, 2023 Mr. MARSHALL introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar bio- logical products as interchangeable. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. STUDY ON THE SUBSTITUTION OF INTER- 3 CHANGEABLE BIOLOGICAL PRODUCTS. 4 (a) REPORT ON BIOSIMILAR BIOLOGICAL PRODUCT 5 INTERCHANGEABILITY.—Not later than 4 years after the 6 date of enactment of this Act, the Secretary of Health and 7 Human Services (referred to in this section as the ‘‘Sec- 8 retary’’), acting through the Commissioner of Food and 9 Drugs, shall submit to the Committee on Health, Edu- 10 VerDate Sep 11 2014 22:59 May 19, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1522.IS S1522 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1522 IS cation, Labor, and Pensions of the Senate and the Com- 1 mittee on Energy and Commerce of the House of Rep- 2 resentatives a report on the designation of biosimilar bio- 3 logical products as interchangeable, under section 4 351(k)(4) of the Public Health Service Act (42 U.S.C. 5 262(k)(4)). Such report shall— 6 (1) describe any challenges faced by manufac- 7 turers in developing and obtaining approval under 8 section 351(k) of such Act for biosimilar biological 9 products that receive such interchangeability des- 10 ignation; 11 (2) summarize the experience of the Food and 12 Drug Administration in reviewing applications for 13 biosimilar biological products that seek an inter- 14 changeability designation, including compared to ap- 15 plications for biosimilar biological products under 16 such section 351(k) that do not seek such designa- 17 tion; 18 (3) summarize, at a high level, the data and in- 19 formation that the Food and Drug Administration 20 has reviewed to support applications for interchange- 21 ability under section 351(k)(4) of such Act, includ- 22 ing data from switching studies, and the differences 23 between the findings from such data and informa- 24 tion compared to the data and information that the 25 VerDate Sep 11 2014 22:59 May 19, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1522.IS S1522 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1522 IS Food and Drug Administration has reviewed for bio- 1 similar biological products that have not received a 2 designation of interchangeability; 3 (4) describe the existing authority of the Food 4 and Drug Administration to determine, on a case- 5 by-case basis, the evidence needed to support an 6 interchangeability designation, and how the Food 7 and Drug Administration has used such authority, 8 including the factors that the agency may consider 9 when making those judgements; 10 (5) describe how the Food and Drug Adminis- 11 tration has considered real-world evidence or other 12 data and information, including from use of the bio- 13 logical product in other countries, in determining 14 whether a biosimilar biological product meets the 15 criteria for the interchangeability designation; 16 (6) describe the differences between the regu- 17 latory and scientific considerations for determining a 18 biological product to be interchangeable under sec- 19 tion 351(k)(4) of such Act (42 U.S.C. 262(k)(4)) 20 and the system for assigning therapeutic equivalence 21 ratings to drugs approved under section 505 of the 22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 23 355); and 24 VerDate Sep 11 2014 22:59 May 19, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1522.IS S1522 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1522 IS (7) assess the uptake of biosimilar biological 1 products, and the impact of the efforts of the Food 2 and Drug Administration to improve adoption of 3 biosimilar biological products through multimedia 4 education and curriculum materials. 5 (b) STAKEHOLDER INPUT.—For purposes of devel- 6 oping the report described in subsection (a), the Secretary 7 may convene workshops or listening sessions, establish 8 dockets to receive public comment, or use other means to 9 obtain input from interested stakeholders. 10 (c) INFORMATION DISCLOSURE.—Nothing in this 11 section shall be construed to authorize the disclosure of 12 information that is prohibited from disclosure under sec- 13 tion 301(j) of the Federal Food, Drug, and Cosmetic Act 14 (21 U.S.C. 331(j)) or section 1905 of title 18, United 15 States Code, or subject to withholding under paragraph 16 (4) of section 552(b) of title 5, United States Code (com- 17 monly referred to as the ‘‘Freedom of Information Act’’). 18 Æ VerDate Sep 11 2014 22:59 May 19, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S1522.IS S1522 kjohnson on DSK79L0C42PROD with BILLS