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1. Biological products are produced from which of the following:

A. Small synthetic molecules B. Large synthetic macromolecules C. Living cell organisms D. Petroleum by products of refinery

2. Biosimilar products are

A. Similar and identical to the brand name reference product B. Dissimilar and distinct from the brand name reference product, with the guarantee of therapeutic equivalency C. Similar and not identical to the brand name reference product, with no guarantee of therapeutic equivalency D. All of the above

3. Which of the following is NOT a step in the development of biosimilar products:

A. Modifying the selected gene of interest B. Gene insertion in host cell C. Harvesting D. Purification of lipid products

4. Which one of the following statements about filgrastim-sndz is TRUE:

A. Indicated for anemia B. Approved for use by children and adults C. No comparable studies required for approval D. It is the generic version of Neupogen

5. Manufacturing challenges for biosimilars impacts which of the following:

A. Product quality B. Product and batch-to-batch variability C. Immunogenicity potential D. All of the above

6. Which one of these data sets is considered insufficient during the biosimilars approval process:

A. Pharmacokinetic B. Efficacy C. Immunogenicity D. Toxicity

7. The substitution of a biosimilar product is determined by

A. Reliable supply sources B. Postmarketing surveillance C. Small-molecule therapy D. Product interchangeability designation

8. Which of the following best describes the U.S. Food and Drug Administration (FDA) Purple Book

A. It is a section of the Orange Book B. It is a listing of licensed biologic products C. It is a listing of all FDA-approved biological products D. It contains postmarket surveillance data for biologic products

9. Which one of the following is the major drawback of indication extrapolation in the use of biosimilars:

A. The risks outweigh the benefits B. The benefits outweigh the risks C. Extrapolation is mandatory for all indications D. Patient communication is prohibited

10. Which one of the following is TRUE about pharmacovigilance:

A. Manufactures are solely responsible B. The purpose is to highlight the differences among products C. It is required only for products with serious safety concerns D. It is intended to safeguard patients by detecting rare reactions associated with products

Maintenance is scheduled for 05/16/2024 5:00 PM EST - 05/17/2024 5:00 AM EST.

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1. Biological products are produced from which of the following:

2. Biosimilar products are

3. Which of the following is NOT a step in the development of biosimilar products:

4. Which one of the following statements about filgrastim-sndz is TRUE:

5. Manufacturing challenges for biosimilars impacts which of the following:

6. Which one of these data sets is considered insufficient during the biosimilars approval process:

7. The substitution of a biosimilar product is determined by

8. Which of the following best describes the U.S. Food and Drug Administration (FDA) Purple Book

9. Which one of the following is the major drawback of indication extrapolation in the use of biosimilars:

10. Which one of the following is TRUE about pharmacovigilance:

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Maintenance is scheduled for 05/16/2024 5:00 PM EST - 05/17/2024 5:00 AM EST.

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1. Biological products are produced from which of the following:

2. Biosimilar products are

3. Which of the following is NOT a step in the development of biosimilar products:

4. Which one of the following statements about filgrastim-sndz is TRUE:

5. Manufacturing challenges for biosimilars impacts which of the following:

6. Which one of these data sets is considered insufficient during the biosimilars approval process:

7. The substitution of a biosimilar product is determined by

8. Which of the following best describes the U.S. Food and Drug Administration (FDA) Purple Book

9. Which one of the following is the major drawback of indication extrapolation in the use of biosimilars:

10. Which one of the following is TRUE about pharmacovigilance:

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