qualifying biosimilar biological product
(8) Biosimilar biological product (A) In general Subject to subparagraph (B), the amount specified in this paragraph for a biosimilar biological product described in paragraph (1)(C) is the sum of— (i) 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 (ii) 6 percent of the amount determined under paragraph (4) for the reference biological product (as defined in subsection (c)(6)(I)). (B) Temporary payment increase (i) In general In the case of a qualifying biosimilar biological product that is furnished during the applicable 5-year period for such product, the amount specified in this paragraph for such product with respect to such period is the sum determined under subparagraph (A), except that clause (ii) of such subparagraph shall be applied by substituting “8 percent” for “6 percent”. (ii) Applicable 5-year period For purposes of clause (i), the applicable 5-year period for a qualifying biosimilar biological product is— (I) in the case of such a product for which payment was made under this paragraph as of September 30, 2022 , the 5-year period beginning on October 1, 2022 ; and (II) in the case of such a product for which payment is first made under this paragraph during a calendar quarter during the period beginning October 1, 2022 , and ending December 31, 2027 , the 5-year period beginning on the first day of such calendar quarter during which such payment is first made. (iii) Qualifying biosimilar biological product defined For purposes of this subparagraph, the term “qualifying biosimilar biological product” means a biosimilar biological product described in paragraph (1)(C) with respect to which— (I) in the case of a product described in clause (ii)(I), the average sales price under paragraph (8)(A)(i) for a calendar quarter during the 5-year period described in such clause is not more than the average sales price under paragraph (4)(A) for such quarter for the reference biological product; and (II) in the case of a product described in clause (ii)(II), the average sales price under paragraph (8)(A)(i) for a calendar quarter during the 5-year period described in such clause is not more than the average sales price under paragraph (4)(A) for such quarter for the reference biological product.