Indiana § 16-42-25-2 "Biosimilar"

Indiana Statutes

§ 16-42-25-2 — "Biosimilar"

Indiana·Title 16 HEALTH·Art. 42 REGULATION OF FOOD, DRUGS, AND·Ch. 25 Drugs: Biosimilar Biological Products

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.

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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.

Indiana § 16-42-25-2 ("Biosimilar") — published by Counsel Stack Legal Research, free access to 12M+ legal documents.