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1. Which of the following is best described as a drug product that may consist of proteins, sugars, nucleic acids, or cells/tissues that has the purpose of preventing, treating, or curing a disease in humans?

A. A biologic B. A small-molecule drug C. A generic D. None of the above

2. Which of the following is NOT a characteristic of biological drug products?

A. They have a high potential for immunogenicity B. They are manufactured using recombinant DNA technology C. They are generally small in size with a low molecular weight D. All of the above are characteristics of biological drugs

3. Which of the following approval pathways can be used for biosimilars to expedite their approval by the United States Food and Drug Administration?

A. New Drug Application defined in section 505(b) of the Food, Drug, and Cosmetic Act (FD&C Act) B. Abbreviated New Drug Application defined in section 505(j) of the FD&C Act C. Biologics License Application defined in section 351(a) of the Public Health Service (PHS) Act D. Biosimilar Biologics License Application defined in section 351(k) of the PHS Act

4. Which of the following best describes the first step required to generate evidence in support of United States Food and Drug Administration approval for a biosimilar?

A. Animal studies to assess pharmacokinetics/pharmacodynamics and immunogenicity B. An analysis of structure and function of the biosimilar C. Clinical studies to assess efficacy and safety D. Pharmacovigilance

5. Which of the following references provides a list of all approved biologics and classifies medications as originators, biosimilars, or interchangeables?

A. The Orange Book B. The Purple Book C. Micromedex D. The Red Book

6. Which of the following is the originator for the biosimilar product Zarxio?

A. Neupogen (filgrastim) B. Lantus (insulin glargine) C. Remicade (infliximab) D. Enbrel (etanercept)

7. Which of the following is a potential advantage of using a naming convention for biosimilars that uses a different 4-letter suffix than the originator product?

A. Less resistance to substitution and easier acceptance of designated status of interchangeability B. Lower costs incurred due to marketing competition of different products C. Easier to track and associate adverse events and/or change in disease with the correct product D. All of the above are potential advantages

8. Which of the following is the originator for the biosimilar product Inflectra?

A. Neupogen (filgrastim) B. Lantus (insulin glargine) C. Remicade (infliximab) D. Enbrel (etanercept)

9. Which of the following is considered a key factor that can contribute to the immunogenic profile of a biologic drug?

A. Product-specific characteristics B. The underlying disease process C. Patient-specific factors D. All of the above

10. Which of the following is NOT considered a key reason why biosimilar agents will never reach levels of price discounting achieved by small-molecule generics?

A. Biosimilar development costs are considerably lower than costs for small-molecule drugs due to the requirement for only pre-clinical and clinical studies for biosimilars B. Biological drug manufacturing costs are higher than small-molecule drug manufacturing costs C. Few biosimilar competitors are expected to enter the market due to the challenges of biosimilar development and marketing, resulting in less intense price competition D. Clinician concerns about comparability may need to be addressed in post-launch studies, which will require additional resources and investment

Maintenance is scheduled for 8/7/2023 7:00 AM EST - 8:00 AM EST.

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1. Which of the following is best described as a drug product that may consist of proteins, sugars, nucleic acids, or cells/tissues that has the purpose of preventing, treating, or curing a disease in humans?

2. Which of the following is NOT a characteristic of biological drug products?

3. Which of the following approval pathways can be used for biosimilars to expedite their approval by the United States Food and Drug Administration?

4. Which of the following best describes the first step required to generate evidence in support of United States Food and Drug Administration approval for a biosimilar?

5. Which of the following references provides a list of all approved biologics and classifies medications as originators, biosimilars, or interchangeables?

6. Which of the following is the originator for the biosimilar product Zarxio?

7. Which of the following is a potential advantage of using a naming convention for biosimilars that uses a different 4-letter suffix than the originator product?

8. Which of the following is the originator for the biosimilar product Inflectra?

9. Which of the following is considered a key factor that can contribute to the immunogenic profile of a biologic drug?

10. Which of the following is NOT considered a key reason why biosimilar agents will never reach levels of price discounting achieved by small-molecule generics?

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Maintenance is scheduled for 8/7/2023 7:00 AM EST - 8:00 AM EST.

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1. Which of the following is best described as a drug product that may consist of proteins, sugars, nucleic acids, or cells/tissues that has the purpose of preventing, treating, or curing a disease in humans?

2. Which of the following is NOT a characteristic of biological drug products?

3. Which of the following approval pathways can be used for biosimilars to expedite their approval by the United States Food and Drug Administration?

4. Which of the following best describes the first step required to generate evidence in support of United States Food and Drug Administration approval for a biosimilar?

5. Which of the following references provides a list of all approved biologics and classifies medications as originators, biosimilars, or interchangeables?

6. Which of the following is the originator for the biosimilar product Zarxio?

7. Which of the following is a potential advantage of using a naming convention for biosimilars that uses a different 4-letter suffix than the originator product?

8. Which of the following is the originator for the biosimilar product Inflectra?

9. Which of the following is considered a key factor that can contribute to the immunogenic profile of a biologic drug?

10. Which of the following is NOT considered a key reason why biosimilar agents will never reach levels of price discounting achieved by small-molecule generics?

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