Page:United States Statutes at Large Volume 124.djvu/832

124 STAT. 806 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(II) may include any additional information in support of the application, including publicly- available information with respect to the reference product or another biological product. ‘‘(B) INTERCHANGEABILITY.—An application (or a supplement to an application) submitted under this sub- section may include information demonstrating that the biological product meets the standards described in para- graph (4). ‘‘(3) EVALUATION BY SECRETARY.—Upon review of an application (or a supplement to an application) submitted under this subsection, the Secretary shall license the biological product under this subsection if— ‘‘(A) the Secretary determines that the information sub- mitted in the application (or the supplement) is sufficient to show that the biological product— ‘‘(i) is biosimilar to the reference product; or ‘‘(ii) meets the standards described in paragraph (4), and therefore is interchangeable with the reference product; and ‘‘(B) the applicant (or other appropriate person) con- sents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). ‘‘(4) SAFETY STANDARDS FOR DETERMINING INTERCHANGE- ABILITY.—Upon review of an application submitted under this subsection or any supplement to such application, the Secretary shall determine the biological product to be interchangeable with the reference product if the Secretary determines that the information submitted in the application (or a supplement to such application) is sufficient to show that— ‘‘(A) the biological product— ‘‘(i) is biosimilar to the reference product; and ‘‘(ii) can be expected to produce the same clinical result as the reference product in any given patient; and ‘‘(B) for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. ‘‘(5) GENERAL RULES.— ‘‘(A) ONE REFERENCE PRODUCT PER APPLICATION.—A biological product, in an application submitted under this subsection, may not be evaluated against more than 1 reference product. ‘‘(B) REVIEW.—An application submitted under this subsection shall be reviewed by the division within the Food and Drug Administration that is responsible for the review and approval of the application under which the reference product is licensed. ‘‘(C) RISK EVALUATION AND MITIGATION STRATEGIES.— The authority of the Secretary with respect to risk evalua- tion and mitigation strategies under the Federal Food, Drug, and Cosmetic Act shall apply to biological products licensed under this subsection in the same manner as Applicability. Determination.