; drug product The terms authorized generic drug , drug substance , and drug product have the respective meanings given such terms in section 314.3 of title 21, Code of Federal Regulations (or any successor regulation). (4) Biological product The term biological product has the meaning given such term in section 351(i)(1) of the Public Health Service Act ( 42 U.S.C. 262(i)(1) ). (5) Licensed biosimilar The term licensed biosimilar means a biological product for which a biologics license has been issued under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ). (6) Produced in the United States The term produced in the United States means that all the production of the material or component takes place in the United States, regardless of the origin of the subcomponents of such material or component. (7) Production The term production means all steps in the manufacture, propagation, and preparation of an eligible component, including synthesis, mixing, granulating, milling, molding, lyophilizing, tableting, encapsulating, coating, sterilizing, testing, filling, labeling, packaging, and storage prior to release by the manufacturer. (d) Special rules Rules similar to the rules of paragraphs (1), (3), and (4) of section 45X(d) shall apply. . (b) Elective payment Section 6417(a) of the Internal Revenue Code of 1986 is amended by adding at the end the following new paragraph: (13) The generic drugs and biosimilars production credit determined under section 45BB. . (c) Conforming amendments (1) Section 38(b) of the Internal Revenue Code of 1986 is amended— (A) in paragraph (40), by striking plus at the end, and (B) in paragraph (41), by striking the period at the end and inserting , plus , and by adding at the end the following new paragraph: (42) the generic drugs and biosimilars production credit determined under section 45BB(a). . (2) The table of sections for subpart D of part IV of subchapter A of chapter 1 of the Internal Revenue Code of 1986 is amended by adding at the end the following new item: