S.C. 262(k) or has been approved based on an application filed under 21 U.S.C. 355(b)(2); and(2) is highly similar to the reference product, with:(A) no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product; and(B) only minor differences in clinically inactive components.As added by P.L.96-2014, SEC.6.
Indiana Legal Code