; (4) by striking paragraph (6); and (5) in paragraph (8)(D)— (A) in clause (i), by striking class; and and inserting class. ; (B) by striking clause (ii); and (C) by striking description of— and all that follows through criteria that the Secretary and inserting description of the criteria that the Secretary . (b) Conforming amendments (1) Section 351(i)(3) of the Public Health Service Act ( 42 U.S.C. 262(i)(3) ) is amended by striking that is shown to meet the standards described in subsection (k)(4) and inserting licensed under subsection (k) . (2) Section 352A of the Public Health Service Act ( 42 U.S.C. 263–1 ) is amended by striking and interchangeable biosimilar biological products each place it appears. (3) Section 744G(14) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51(14) ) is amended by striking , including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in section 351(k)(4) of the Public Health Service Act . (4) By amending subsection (l) of section 505B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c ) to read as follows: (l) Biosimilar biological products A biological product for which an application is submitted under section 351(k) of the Public Health Service Act shall be considered to have a new active ingredient for purposes of this section, except that a pediatric assessment shall not be required for a claimed indication in a relevant pediatric population if the assessment would involve— (1) a condition of use that has not been previously approved for the reference product