DEFINITIONS.

SEC. 402. DEFINITIONS. (a) Adjustment Factor.—Section 744G(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows: “(1) The term ‘adjustment factor’ applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items) for October of the preceding fiscal year divided by such Index for October 2011.” . (b) Biosimilar Biological Product.—Section 744G(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3)) is amended by striking “means a product” and inserting “means a specific strength of a biological product in final dosage form”.