Indiana Code 16-42-25-2. “Biosimilar”
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Sec. 2. As used in this chapter, “biosimilar” refers to a biological product that:
(2) is highly similar to the reference product, with:
(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
Terms Used In Indiana Code 16-42-25-2
- biological product: means :
Indiana Code 16-42-25-1
- biosimilar: refers to a biological product that:
Indiana Code 16-42-25-2
- minor: means a person less than eighteen (18) years of age. See Indiana Code 1-1-4-5
(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.