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1. For FDA approval, a biosimilar must demonstrate:

A. No clinically meaningful differences with the reference biologic in terms of structure, safety, purity, and potency B. No clinically meaningful differences with the reference biologic in terms of structure, safety, purity, potency, and efficacy C. No clinically meaningful differences with the reference biologic in terms of safety, purity, and potency D. No clinically meaningful differences with the reference biologic in terms of safety, purity, potency, and efficacy

2. Which of the following references may be used to identify whether a biological product has been determined by the FDA to be a biosimilar to a reference product?

A. Red Book B. Orange Book C. Purple Book D. Black Book

3. Which of the following is true about interchangeability of biosimilars?

A. State legislature will determine whether pharmacists are permitted to substitute an interchangeable biosimilar for a brand-name biologic without physician intervention B. The designation of “interchangeability” is equivalent to the standards set forth for “biosimilarity” C. A period of 5-year exclusivity will be granted to the first biosimilar of a reference product that receives interchangeable designation D. Minimal pharmacovigilance will be required for interchangeable biosimilars

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