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136 STAT. 1855 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(A) IN GENERAL.—Subject to subparagraph (B), in the case of a biological product that would (but for this sub- section) be an extended-monopoly drug (as defined in sec- tion 1194(c)(4)) included as a selected drug on the list published under subsection (a) with respect to an initial price applicability year, the rules described in paragraph (2) shall apply if the Secretary determines that there is a high likelihood (as described in paragraph (3)) that a biosimilar biological product (for which such biological product will be the reference product) will be licensed and marketed under section 351(k) of the Public Health Service Act before the date that is 2 years after the selected drug publication date with respect to such initial price applica- bility year. ‘‘(B) REQUEST REQUIRED.— ‘‘(i) IN GENERAL.—The Secretary shall not provide for a delay under— ‘‘(I) paragraph (2)(A) unless a request is made for such a delay by a manufacturer of a biosimilar biological product prior to the selected drug publication date for the list published under sub- section (a) with respect to the initial price applica- bility year for which the biological product may have been included as a selected drug on such list but for subparagraph (2)(A); or ‘‘(II) paragraph (2)(B)(iii) unless a request is made for such a delay by such a manufacturer prior to the selected drug publication date for the list published under subsection (a) with respect to the initial price applicability year that is 1 year after the initial price applicability year for which the biological product described in sub- section (a) would have been included as a selected drug on such list but for paragraph (2)(A). ‘‘(ii) INFORMATION AND DOCUMENTS.— ‘‘(I) IN GENERAL.—A request made under clause (i) shall be submitted to the Secretary by such manufacturer at a time and in a form and manner specified by the Secretary, and contain— ‘‘(aa) information and documents nec- essary for the Secretary to make determina- tions under this subsection, as specified by the Secretary and including, to the extent available, items described in subclause (III); and ‘‘(bb) all agreements related to the bio- similar biological product filed with the Fed- eral Trade Commission or the Assistant Attorney General pursuant to subsections (a) and (c) of section 1112 of the Medicare Prescription Drug, Improvement, and Mod- ernization Act of 2003. ‘‘(II) ADDITIONAL INFORMATION AND DOCU- MENTS.—After the Secretary has reviewed the request and materials submitted under subclause (I), the manufacturer shall submit any additional Time period. Determination. Time period. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00039 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw