Sec. 3139. PAYMENT FOR BIOSIMILAR BIOLOGICAL PRODUCTS

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## SEC. 3139 PAYMENT FOR BIOSIMILAR BIOLOGICAL PRODUCTS ###

(a)In General Section 1847A of the Social Security Act (42 U.S.C. 1395w–3a) is amended— ####

(1)in subsection (b)— #####

(A)in paragraph (1)— ######

(i)in subparagraph (A), by striking “or” at the end; ######

(ii)in subparagraph (B), by striking the period at the end and inserting “; or”; and ######

(iii)by adding at the end the following new subparagraph: > > ##### “(C) > > in the case of a biosimilar biological product (as defined in subsection (c)(6)(H)), the amount determined under paragraph (8).” > ; and #####

(B)by adding at the end the following new paragraph: > > #### “(8) Biosimilar biological product > > The amount specified in this paragraph for a biosimilar biological product described in paragraph (1)(C) is the sum of— > > > ##### “(A) > > the average sales price as determined using the methodology described under paragraph

(6)applied to a biosimilar biological product for all National Drug Codes assigned to such product in the same manner as such paragraph is applied to drugs described in such paragraph; and > > > ##### “(B) > > 6 percent of the amount determined under paragraph

(4)for the reference biological product (as defined in subsection (c)(6)(I)).” > ; and ####

(2)in subsection (c)(6), by adding at the end the following new subparagraph: > > ##### “(H) Biosimilar biological product > > The term ‘**biosimilar biological product**’ means a biological product approved under an abbreviated application for a license of a biological product that relies in part on data or information in an application for another biological product licensed under section 351 of the Public Health Service Act. > > > ##### “(I) Reference Biological product > > The term ‘**reference biological product**’ means the biological product licensed under such section 351 that is referred to in the application described in subparagraph

(H)of the biosimilar biological product.” > . ###

(b)Effective Date **[**[42 U.S.C. 1395w–3a note](/us/usc/t42/s1395w–3a)**]** The amendments made by subsection

(a)shall apply to payments for biosimilar biological products beginning with the first day of the second calendar quarter after enactment of legislation providing for a biosimilar pathway (as determined by the Secretary).

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42 USC 1395w–3a

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Sec. 3139

PAYMENT FOR BIOSIMILAR BIOLOGICAL PRODUCTS

Cite42 USC 1395w–3a

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