IC 16-42-25-2: "Biosimilar"

Sec. 2. 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.