II 

116TH CONGRESS 

1ST SESSION S. 1681 

To educate health care providers and the public on biosimilar biological 

products, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 23 (legislative day, MAY 22), 2019 

Mr. ENZI (for himself and Ms. HASSAN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To educate health care providers and the public on biosimilar 

biological products, and for other purposes. 

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 ‘‘Advancing Education 

5 on Biosimilars Act of 2019’’. 

6 SEC. 2. EDUCATION ON BIOLOGICAL PRODUCTS. 

7 (a) IN GENERAL.—Subpart 1 of part F of title III 

8 of the Public Health Service Act (42 U.S.C. 262 et seq.) 

9 is amended by adding at the end the following: 


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1 ‘‘SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS. 

2 ‘‘(a) INTERNET WEBSITE.— 

3 ‘‘(1) IN GENERAL.—The Secretary shall estab4 lish, maintain, and operate an internet website con5 sisting of educational materials regarding the mean6 ing and use of biosimilar biological products and 

7 interchangeable biological products. 

8 ‘‘(2) FORMAT.—The educational materials pro9 vided under paragraph (1)— 

10 ‘‘(A) may be in the form of webinars, con11 tinuing medical education modules, videos, fact 

12 sheets, infographics, stakeholder toolkits, or 

13 other formats, as the Secretary determines ap14 propriate; 

15 ‘‘(B) shall be presented in a manner, using 

16 simple terminology, that is easily comprehended 

17 by appropriate target audiences, including ac18 counting, to the extent practicable, for varying 

19 levels of health literacy among patients and 

20 caregivers; 

21 ‘‘(C) shall be tailored for the unique needs 

22 of appropriate target audiences, including— 

23 ‘‘(i) health care providers with pre24 scribing authority or dispensing authority 

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1 cian assistants, pharmacists, and phar2 macy technicians; and 

3 ‘‘(ii) patients and caregivers; and 

4 ‘‘(D) may, as appropriate, be additionally 

5 tailored to health care providers practicing in 

6 specialties in which biological products com7 monly are prescribed or to patient populations 

8 to whom biological products commonly are pre9 scribed or administered. 

10 ‘‘(3) CONTENT.—Educational materials pro11 vided under paragraph (1) shall include explanations 

12 of— 

13 ‘‘(A) key statutory and regulatory defini14 tions, including the definitions of the terms 

15 ‘biosimilar’ and ‘interchangeable’, and clarifica16 tion that an interchangeable product is not su17 perior in quality to a biosimilar biological prod18 uct; 

19 ‘‘(B) how the Secretary determines the 

20 safety, purity, and potency of biological prod21 ucts that are the subjects of applications under 

22 subsections (a) and (k) of section 351; 

23 ‘‘(C) the application of the same quality 

24 and manufacturing standards for biological 

25 products under 351(a), biosimilar biological 


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1 products under 351(k), and interchangeable bi2 ological products under 351(k)(4); 

3 ‘‘(D) the development program and totality 

4 of the evidence required for biosimilar biological 

5 product development and how prescribers can 

6 evaluate such information; 

7 ‘‘(E) the process for reporting adverse 

8 events for all biological products, including bio9 similar and interchangeable biological products; 

10 ‘‘(F) the relationship between— 

11 ‘‘(i) variation among biological prod12 ucts licensed under section 351(k) and 

13 their reference products licensed under sec14 tion 351(a); and 

15 ‘‘(ii) lot-to-lot variability for a biologi16 cal product licensed under section 351(a) 

17 or section 351(k) (including interchange18 able biological products); 

19 ‘‘(G) how the Food and Drug Administra20 tion assesses data regarding the risk of 

21 immunogenicity for originator biological prod22 ucts licensed under section 351(a) and bio23 similar biological products licensed under sec24 tion 351(k); 


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1 ‘‘(H) whether the role of analytical charac2 terization is novel to biosimilar biological prod3 uct development; and 

4 ‘‘(I) how the Food and Drug Administra5 tion considers biosimilar biological products to 

6 be as safe and effective as their reference prod7 ucts. 

8 ‘‘(4) OTHER INFORMATION.—In addition to the 

9 information described in paragraph (3), the internet 

10 website established under paragraph (1) shall in11 clude the following information (with redactions as 

12 required by law for trade secret and confidential 

13 commercial information), as a single, searchable 

14 database: 

15 ‘‘(A) The action package of each biological 

16 product licensed under subsection (a) or (k), 

17 within 30 days of approval of the application, 

18 or, in the case of a biological product licensed 

19 before the date of enactment of the Advancing 

20 Education on Biosimilars Act of 2019, not later 

21 than 1 year after such date of enactment. 

22 ‘‘(B) The summary review of each biologi23 cal product licensed under subsection (a) or (k), 

24 within 48 hours of approval of the application, 

25 or, in the case of a biological product licensed 


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1 before the date of enactment of the Advancing 

2 Education on Biosimilars Act of 2019, not later 

3 than 1 year after such date of enactment. 

4 ‘‘(C) The history and timing of manufac5 turing changes with respect to biological prod6 ucts licensed under section 351(a). 

7 ‘‘(b) CONTINUING MEDICAL EDUCATION.—The Sec8 retary shall advance education and awareness among 

9 health care providers regarding biosimilar biological prod10 ucts, including by developing or improving continuing 

11 medical education programs that advance the education 

12 of such providers on the prescribing of, and relevant clin13 ical considerations with respect to, biosimilar biological 

14 products.’’. 

15 (b) APPLICATION UNDER THE MEDICARE MERIT16 BASED INCENTIVE PAYMENT SYSTEM.—Section 

17 1848(q)(5)(C) of the Social Security Act (42 U.S.C. 

18 1395w–4(q)(5)(C)) is amended by adding at the end the 

19 following new clause: 

20 ‘‘(iv) CLINICAL MEDICAL EDUCATION

21 PROGRAM ON BIOSIMILAR BIOLOGICAL

22 PRODUCTS.—Completion of a clinical med23 ical education program developed or im24 proved under section 352A(b) of the Public 

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1 fessional during a performance period shall 

2 earn such eligible professional one-half of 

3 the highest potential score for the perform4 ance category described in paragraph 

5 (2)(A)(iii) for such performance period. A 

6 MIPS eligible professional may only count 

7 the completion of such a program for pur8 poses of such category one time during the 

9 eligible professional’s lifetime.’’. 

Æ 


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