1. Which of the following is true relative to the approval process for biosimilar medications in the United States?
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a. Biosimilars only need to show chemical equivalence to be approved
b. Biosimilars require clinical trial data showing biological and clinical equivalence to the reference product to be approved
c. Biosimilars require placebo-controlled trial data to be approved
d. Biosimilars must be produced in the exact same cell lines to be approved
2. Which of the following is false about switching patients from a reference product to a biosimilar?
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a. Patient experience can be dictated by the nocebo effect
b. Patients require education about biosimilars in order to avoid misunderstandings about what to expect
c. Patients understand what biosimilars are and how they achieve approval status
d. Expansion of biosimilar usage has led to significant benefits to health systems and patients
3. Which of the following is incorrect regarding anti-CD20 monoclonal antibody use in multiple sclerosis:
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a. Infusion related reactions are seen in over 30% of patients at the time of first infusion regardless of anti-CD20 used
b. Anti-CD20 monoclonal antibodies are associated with a higher rate of infections than most other disease modifying therapies
c. Urinary tract infections are the most common infection seen with anti-CD20 monoclonal antibodies
d. A decrease in IgM antibody levels is more commonly observed with anti-CD20 monoclonal antibody than a decrease in IgG
e. Neutropenia may be observed with anti-CD20 monoclonal antibodies
4. Which of the following is correct with respect to anti-CD20 monoclonal antibody usage during pregnancy and breastfeeding?
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a. The placenta freely allows passage of the antibody into the developing fetus
b. The half life of anti-CD20s is 18-32 days; therefore, there is no potential exposure to the drug 3 months (5 - half lifes) after administration
c. The use of anti-CD20 monoclonal antibodies prior to pregnancy has no material effect on maternal relapse rates
d. Exposure to anti-CD20s, even in late trimesters, has no effect on the neonate
e. Anti-CD20 monoclonal antibodies cross into breast milk at high levels
5. MS pathogenesis involves:
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a. T cells
b. B cells
c. Anti-astrocyte antibody
d. Both a and b
6. CD40 is:
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a. An antibody
b. A B cell marker
c. A coactivation molecule
d. An adhesion molecule
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