Section 16-42-25-2 - "Biosimilar" As used in this chapter, "biosimilar" refers to a biological product that:
(1) has been licensed as a biosimilar product under 41 U.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.Added by P.L. 96-2014, SEC. 6, eff. 7/1/2014.