{"data":{"id":"us-in/ic-16-42-25-2","jurisdiction":"us-in","citation":"IC 16-42-25-2","heading":"\"Biosimilar\"","body":"Sec. 2. As used in this chapter, \"biosimilar\" refers to a biological product that:\n(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\n(2) is highly similar to the reference product, with:\n(A) no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product; and\n(B) only minor differences in clinically inactive components.","path":["TITLE 16. HEALTH","ARTICLE 42. REGULATION OF FOOD, DRUGS, AND COSMETICS","Chapter 25. Drugs: Biosimilar Biological Products"],"source_url":"https://iga.in.gov/ic/2026/Title_16.html#16-42-25-2","current_through":"2026","vintage":"2026","retrieved_at":"2026-09-11T20:02:18Z","sha256":"92a84c556de46730cd1676ed1c20bc7e3ad59f90222d79fc5b4a4c807ed91df2","source_id":"us-in","stale":false,"prev":"us-in/ic-16-42-25-1","next":"us-in/ic-16-42-25-3"},"notice":"GroundRules: Original legal text. Not legal advice."}