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1. Which of the following was the first U.S. Food and Drug Administration (FDA)-approved biologic for human use:

A. Infliximab B. Erythropoietin C. Interferon D. Insulin

2. The abbreviated regulatory approval pathway for biosimilars was established by which of the following Acts:

A. Hatch-Waxman Act B. Biologics Price Competition and Innovation Act of 2009 C. Federal Food, Drug, and Cosmetics Act D. Public Health Service Act

3. The FDA has allotted innovator biologics how many years of exclusivity under the abbreviated regulatory pathway for biosimilars?

A. 12 B. 4 C. 11 D. 5

4. Which of the following statements is NOT correct:

A. Biosimilars can only be highly similar but not identical to an innovator product B. Biosimilars will retain the same FDA-approved indications as the innovator product C. Biosimilars will be evaluated according to a risk based, totality-of-the-evidence approach D. Biosimilars are derived from living systems, such as viruses and plant cells

5. The increased incidence of pure red blood cell aplasia (PRCA) that occurred in Europe in the late 1990s was associated with which of the following biologics:

A. Erythropoietin B. Somatropin C. Heparin D. Granulocyte colony-stimulating factor

6. Specific guidance from the FDA is still unclear with regard to which of the following topics concerning biosimilars:

A. Product naming B. Product interchange C. Product-specific class requirements D. All of the above

7. Which of the following statements is NOT correct with regard to therapeutic interchange programs:

A. They offer substantial cost savings B. They are not permitted without FDA approval C. They are typically established by a multidisciplinary committee D. They typically have “opt out” clauses for unique circumstances

8. Which of the following factors should be included in formulary decisions with regard to biosimilars:

A. Immunogenicity profile B. FDA-approved indications C. Cost D. All of the above

9. Which of the following statements is TRUE with regard to tbo-filgrastim:

A. It is the first FDA-approved biosimilar B. It did not retain the same FDA-approved indications as the innovator product, filgrastim C. It did retain the same FDA-approved indication as the innovator product, filgrastim D. All of the above

10. The degree of market penetration with regard to biosimilars will depend on which of the following:

A. The size of the biosimilar market B. Laws related to biosimilar substitution C. Payers' systems and policies D. All of the above

Evaluation Questions

11. To what extent did the program meet objective #1?

A. Excellent B. Very Good C. Good D. Fair E. Poor

12. To what extent did the program meet objective #2?

A. Excellent B. Very Good C. Good D. Fair E. Poor

13. To what extent did the program meet objective #3?

A. Excellent B. Very Good C. Good D. Fair E. Poor

14. To what extent did the program meet objective #4?

A. Excellent B. Very Good C. Good D. Fair E. Poor

15. Rate the effectiveness of how well the program related to your educational needs:

A. Excellent B. Very Good C. Good D. Fair E. Poor

16. Rate how well the active learning strategies (questions, cases, discussions) were appropriate and effective learning tools:

A. Excellent B. Very Good C. Good D. Fair E. Poor

17. Rate the quality of the faculty:

A. Excellent B. Very Good C. Good D. Fair E. Poor

18. Rate the effectiveness and the overall usefulness of the material presented:

A. Excellent B. Very Good C. Good D. Fair E. Poor

19. Rate the appropriateness of the examination for this activity:

A. Excellent B. Very Good C. Good D. Fair E. Poor

20. Rate the effectiveness of how well the activity related to your practice needs:

A. Excellent B. Very Good C. Good D. Fair E. Poor

21. Rate the effectiveness of how well the activity will help you improve patient care:

A. Excellent B. Very Good C. Good D. Fair E. Poor

22. Will the information presented cause you to change your practice?

A. Yes B. No

23. Are you committed to making these changes?

A. Yes B. No

24. As a result of this activity, did you learn something new?

A. Yes B. No

25. What is your practice setting or area of practice?

A. Community Pharmacy/Independent B. Community Pharmacy/Chain C. Hospital/Health Systems D. Administrative/Pharmacy Director E. Critical Care Pharmacy F. Long-term Care G. Managed Care/PBM H. Oncology/Specialty Pharmacy I. Industry/Manufacturing

26. How many years have you been in practice?

A. <5 B. 5 – 10 C. 11 – 20 D. >20

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