; or with respect to a drug for which there is no average manufacturer price as so defined, such term shall mean the wholesale acquisition cost (as defined in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B)) of the drug. (B) Application to reference countries With respect to reference countries, the term average manufacturer price , as defined in subparagraph (A), shall be determined based on the price of the drug in the applicable reference country. (2) Biosimilar biological product The term biosimilar biological product means a biological product licensed pursuant to an application under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ). (3) Generic drug The term generic drug means a drug approved pursuant to an application under section (b)(2) or (j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ). (4) Life-sustaining prescription drug The term life-sustaining prescription drug means a drug that is— (A) approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or a biological product licensed under subsection (a) or (k) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); (B) subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(b)(1) ); and (C) life-sustaining (as such term is defined in regulation pursuant to section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c )). (5) Manufacturer The term manufacturer means the holder of an application approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or of a license issued under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). (6) Secretary The term Secretary means the Secretary of Health and Human Services.