Section 3139

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- 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].