CE- Current State of Biosimilars Quiz CE -The Current State of Biosimilars ACPE # 0278-0000-15-045-H01-P ACPE # 0278-0000-15-045-H01-T 1Contact2Quiz Name* First Last Email* Phone*Attendee Type* Pharmacist Technician Which of the following available references for pharmacists contains all approved biologics and classifies medications as originators, biosimilars, or interchangeable medications?* The Orange Book The Purple Book The Red Book All of the above contain this information A Biosimilar must demonstrate the following for FDA approval:* No clinically meaningful differences with the reference product in regards to efficacy, safety, purity and potency No clinically meaningful differences with the reference product in regards to safety, purity, and potency No clinically meaningful differences with the reference product in regards to safety, pharmacology, potency, efficacy No clinically meaningful differences with the reference product in regards to safety, efficacy, and pharmacology Cited reasons of using different suffix biosimilar naming convention for biosimilars that uses a different 4-letter suffix than the originator product include:* Less resistance by patients to using a biosimilar product versus the reference product More accurate tracking of adverse events and accurate attribution to product Lower costs to the patient due to marketing competition of different products All of the above are potential advantages Currently the EU has more marketed biosimilar products than does the US* True False Which of the following statements is incorrect:* State legislature determines whether pharmacists are permitted to substitute an interchangeable biosimilar for a brand-name biologi without physician intervention An interchangeable biologic product may be substituted for the reference product without the intervention of the prescriber Current challenges to conducting observational studies in the US include lack of data sources, challenging study designs and assessing outcomes All approved biologics in the United States are deemed interchangeable with their reference product Δ
