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.
As added by P.L.96-2014, SEC.6.
Structure Indiana Code
Article 42. Regulation of Food, Drugs, and Cosmetics
Chapter 25. Drugs: Biosimilar Biological Products
16-42-25-1. "Biological Product"
16-42-25-4. Substitution; Conditions
16-42-25-5. Records of Dispensing Biologic Product; Time Frame; Exception
16-42-25-6. Record Retention; Pharmacy; Prescribing Practitioner
16-42-25-7. Link to Current List of Interchangeable Biological Products; Rules