Indiana § 16-42-25-2 "Biosimilar"

Indiana Statutes

§ 16-42-25-2 — "Biosimilar"

Indiana § 16-42-25-2

Title 16HEALTH

Art. 42REGULATION OF FOOD, DRUGS, AND

Ch. 25Drugs: Biosimilar Biological Products

This text of Indiana § 16-42-25-2 ("Biosimilar") is published on Counsel Stack Legal Research, covering Indiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

Ind. Code § 16-42-25-2 (2026).

Text

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.

Free access — add to your briefcase to read the full text and ask questions with AI

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.