124 STAT. 805 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR INTERCHANGEABLE.— ‘‘(1) IN GENERAL.—Any person may submit an application for licensure of a biological product under this subsection. ‘‘(2) CONTENT.— ‘‘(A) IN GENERAL.— ‘‘(i) REQUIRED INFORMATION.—An application sub- mitted under this subsection shall include information demonstrating that— ‘‘(I) the biological product is biosimilar to a reference product based upon data derived from— ‘‘(aa) analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive compo- nents; ‘‘(bb) animal studies (including the assess- ment of toxicity); and ‘‘(cc) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate condi- tions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product; ‘‘(II) the biological product and reference product utilize the same mechanism or mecha- nisms of action for the condition or conditions of use prescribed, recommended, or suggested in the proposed labeling, but only to the extent the mechanism or mechanisms of action are known for the reference product; ‘‘(III) the condition or conditions of use pre- scribed, recommended, or suggested in the labeling proposed for the biological product have been pre- viously approved for the reference product; ‘‘(IV) the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product; and ‘‘(V) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent. ‘‘(ii) DETERMINATION BY SECRETARY.—The Sec- retary may determine, in the Secretary’s discretion, that an element described in clause (i)(I) is unnecessary in an application submitted under this subsection. ‘‘(iii) ADDITIONAL INFORMATION.—An application submitted under this subsection— ‘‘(I) shall include publicly-available informa- tion regarding the Secretary’s previous determina- tion that the reference product is safe, pure, and potent; and Public information.
