Page:United States Statutes at Large Volume 124.djvu/843

 124 STAT. 817 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(n) NEW ACTIVE INGREDIENT.— ‘‘(1) NON-INTERCHANGEABLE BIOSIMILAR BIOLOGICAL PRODUCT.—A biological product that is biosimilar to a reference product under section 351 of the Public Health Service Act, and that the Secretary has not determined to meet the stand- ards described in subsection (k)(4) of such section for inter- changeability with the reference product, shall be considered to have a new active ingredient under this section. ‘‘(2) INTERCHANGEABLE BIOSIMILAR BIOLOGICAL PRODUCT.— A biological product that is interchangeable with a reference product under section 351 of the Public Health Service Act shall not be considered to have a new active ingredient under this section.’’. (e) PRODUCTS PREVIOUSLY APPROVED UNDER SECTION 505.— (1) REQUIREMENT TO FOLLOW SECTION 351.—Except as pro- vided in paragraph (2), an application for a biological product shall be submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) (as amended by this Act). (2) EXCEPTION.—An application for a biological product may be submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) if— (A) such biological product is in a product class for which a biological product in such product class is the subject of an application approved under such section 505 not later than the date of enactment of this Act; and (B) such application— (i) has been submitted to the Secretary of Health and Human Services (referred to in this subtitle as the ‘‘Secretary’’) before the date of enactment of this Act; or (ii) is submitted to the Secretary not later than the date that is 10 years after the date of enactment of this Act. (3) LIMITATION.—Notwithstanding paragraph (2), an application for a biological product may not be submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) if there is another biological product approved under subsection (a) of section 351 of the Public Health Service Act that could be a reference product with respect to such application (within the meaning of such section 351) if such application were submitted under subsection (k) of such section 351. (4) DEEMED APPROVED UNDER SECTION 351.—An approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) shall be deemed to be a license for the biological product under such section 351 on the date that is 10 years after the date of enactment of this Act. (5) DEFINITIONS.—For purposes of this subsection, the term ‘‘biological product’’ has the meaning given such term under section 351 of the Public Health Service Act (42 U.S.C. 262) (as amended by this Act). (f) FOLLOW-ON BIOLOGICS USER FEES.— (1) DEVELOPMENT OF USER FEES FOR BIOSIMILAR BIOLOGICAL PRODUCTS.— (A) IN GENERAL.—Beginning not later than October 1, 2010, the Secretary shall develop recommendations to Deadline. Recommenda- tions. Effective date. Deadlines. 42 USC 262 note.