1. A biosimilar is defined as
A. A newly discovered biological product that is unlike any other biologic product on the market
B. A biologic highly similar to an approved reference product with comparable efficacy, purity, and safety
C. A small-molecule reference product that has already been approved by the U.S. Food and Drug Administration
D. A generic drug with pharmacokinetic and pharmacodynamic properties similar to those of the originator product
E. Unsure
2. When used in conjunction with biosimilars, the term “extrapolation” refers to
A. Inferring that the biosimilar is as efficacious as the originator product with a comparable adverse effect profile
B. Expansion of the biosimilar's use to closely related indications of its originator product without additional clinical trials
C. Inferring clinical efficacy of a biosimilar based on available preclinical, pharmacokinetic, and safety data
D. The ability of pharmacists to substitute an interchangeable biosimilar for its originator without prescriber intervention
E. Unsure
3. Biosimilars are designated by a unique naming system consisting of a
A. Proprietary drug name followed by a random numeric suffix
B. Nonproprietary reference biologic name followed by a numeric suffix
C. Proprietary drug name followed by a random 3-letter suffix
D. Nonproprietary reference biologic name followed by a 4-letter suffix
E. Unsure
4. You are considering using a G-CSF biosimilar for prophylactic neutropenia management in your patient with advanced non-small cell lung cancer receiving myelosuppressive chemotherapy. Current American Society of Clinical Oncology guidelines indicate that
A. An FDA-approved biosimilar is not an appropriate substitute for filgrastim or pegfilgrastim
B. Filgrastim-aafi is the only biosimilar approved for prophylactic neutropenia management
C. An FDA-approved biosimilar is an appropriate substitute for filgrastim and pegfilgrastim
D. Filgrastim biosimilars can only be used for Hematopoietic Syndrome of Acute Radiation Syndrome
E. Unsure
5. Compared with the originator compound, studies of filgrastim biosimilars have found
A. No significant difference in safety profiles
B. A higher incidence of cardiotoxicity only
C. More immunogenicity and less cardiotoxicity
D. Increased hematologic toxicity and immunogenicity
E. Unsure
6. You are considering treatment with a pegfilgrastim biosimilar for chemotherapy-induced febrile neutropenia prophylaxis for your patient receiving myelosuppressive chemotherapy. Your patient has heard about filgrastim and asks how this drug differs. You inform him that
A. It is a form of recombinant G-CSF chemically modified to reduce its immunogenicity
B. It produces the same effect as filgrastim but requires daily administration
C. It is a generic form of filgrastim that will likely be covered by his insurance
D. It is a form of recombinant G-CSF modified to increase its half-life and reduce its clearance
E. Unsure
7. Multiple real-world studies comparing G-CSF reference compounds with its biosimilars have found
A. Significantly better efficacy with biosimilars
B. Significantly worse efficacy with biosimilars
C. No substantial efficacy differences with biosimilars
D. Better efficacy but increased toxicity with biosimilars
E. Unsure
8. You are considering either pegfilgrastim injection or pegfilgrastim administered through an on-body injector device (PEG-OBI) for your patient with disabilities who has difficulty coming to clinic for regular G-CSF therapy. One factor to consider is
A. The reported failure rate with PEG-OBI at-home administration
B. A potential higher treatment cost associated with injected pegfilgrastim
C. The potential to use a pegfilgrastim biosimilar with PEG-OBI
D. Increased adverse effects with PEG-OBI compared with injected pegfilgrastim
E. Unsure
9. Your patient with metastatic breast cancer is receiving a filgrastim biosimilar for chemotherapy-associated neutropenia and now is experiencing bone pain. You advise her that
A. This is a reported side effect of filgrastim biosimilar therapy
B. This is unlikely to be related to filgrastim biosimilar therapy
C. She should wait it out, as it will likely spontaneously resolve
D. It is most likely related to her chemotherapy regimen
E. Unsure
10. One of the largest barriers to more widespread clinical adoption of G-CSF biosimilars in the United States is believed to be
A. Patient education and acceptance
B. Treatment-related adverse effects
C. Physician experience and confidence
D. Patent litigation and regulatory processes
E. Unsure
Evaluation Questions
11. How confident are in your treatment choice for the patients in the questions above?
A. Not at all confident
B. Somewhat confident
C. Confident
D. Highly confident
