IC 16-42-25-3: "Interchangeable"

Sec. 3. As used in this chapter, "interchangeable" means:

(1) a determination by the federal Food and Drug Administration that a biosimilar product may be substituted for a reference biological product without the intervention of the health care provider that prescribed the biological product; or

(2) concerning a biological product filed under 21 U.S.C. 355(b)(2), a product that is designated as therapeutically equivalent by the federal Food and Drug Administration in the Approved Drug Products with Therapeutic Equivalence Evaluations.