 See References in Text note below.

and

 So in original.

(I)(bb) and (III) of paragraph (1)(B)(ii) submitted to the Secretary by the manufacturer requesting a delay under such paragraph provides clear and convincing evidence that such biosimilar biological product will, within the time period specified under paragraph (1)(A) or (2)(B)(i)(I), be marketed.

Editorial Notes

References in Text

Section 52 of the Internal Revenue Code of 1986, referred to in subsecs. (d)(2)(B)(i) and (f)(1)(C)(i), is classified to section 52 of Title 26, Internal Revenue Code.

Section 262(a) of this title, referred to in subsec. (e)(2)(B)(ii)(I), was in the original “section 351(a) of such Act” and was translated as reading “section 351(a) of the Public Health Service Act”, to reflect the probable intent of Congress.

Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (f)(1)(B)(ii)(I)(bb), is section 1112 of Pub. L. 108–173, which is set out in a note under section 355 of Title 21, Food and Drugs.

Amendments

2022—Subsec. (a). Pub. L. 117–169, § 11002(a)(1)(A), inserted “and subsection (b)(3)” after “the previous sentence” in concluding provisions.

Subsec. (b)(1)(C). Pub. L. 117–169, § 11002(a)(1)(B)(i), added subpar. (C).

Subsec. (b)(3). Pub. L. 117–169, § 11002(a)(1)(B)(ii), added par. (3).

Subsec. (f). Pub. L. 117–169, § 11002(a)(1)(C), added subsec. (f).

Statutory Notes and Related Subsidiaries

Implementation for 2026 Through 2028

Pub. L. 117–169, title I, § 11002(c), Aug. 16, 2022, 136 Stat. 1862, provided that: “The Secretary of Health and Human Services shall implement this section [amending this section and sections 1320f–2, 1320f–5 to 1320f–7, and 1396r–8 of this title], including the amendments made by this section, for 2026, 2027, and 2028 by program instruction or other forms of program guidance.”