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1. Which of the following statements regarding the US Food and Drug Administration (FDA) regulatory pathway for biosimilar approval is CORRECT?
A. Biosimilars must be structurally identical to their reference biologic.
B. Biosimilars may demonstrate +/- 20% difference in efficacy compared to their reference biologic.
C. Biosimilars may demonstrate minor differences in clinically inactive components.
D. Biosimilars may display slightly different safety profiles compared to their reference biologic, as long as these safety considerations are indicated on the prescribing label.
2. As of September 2018, the US Food and Drug Administration has approved biosimilar agents for all the following reference agents EXCEPT:
3. JP, a 54-year-old female patient with a history of rheumatoid arthritis, has been experiencing stable disease utilizing infliximab. She presents to refill her prescription and indicates that she is concerned over the cost of maintaining her treatment, as she has recently become the primary caregiver for her young grandson. She indicates she has heard about a generic version of infliximab and wonders if it might be a good option for her, but wants to make sure that it works just as well as what she is taking now. Which of the following are you MOST LIKELY to tell JP about the use of a biosimilar for infliximab?
A. Inform her that since she is stable on her current treatment regimen, she is not an appropriate candidate to switch from the reference biologic, as biosimilar infliximab is only indicated for infliximab-naïve patients.
B. Reassure her about switching because, like a generic, biosimilar infliximab is produced in exactly the same way as its reference drug, and thus, they are identical.
C. Reassure her about switching, and inform her that there is only a minimally increased risk of infusion reaction with switching to biosimilar infliximab.
D. Reassure her about switching and explain that biosimilar infliximab has gone through a rigorous approval process and no differences in efficacy or safety are anticipated.
4. Which of the following statements regarding the use of biosimilar therapies in patient management is TRUE?
A. Biosimilar therapies have been US Food and Drug Administration (FDA)-approved across a variety of clinical indications but are not yet incorporated into clinical practice guidelines.
B. As of September 2018, no biosimilars approved by the US FDA have been labeled as “interchangeable” with their reference biologic.
C. Safety profiles of each approved biosimilar have been established through clinical trials, which are required as part of the FDA approval process for biosimilars.
D. Efficacy profiles of each approved biosimilar indication have been established through clinical trials, which are required as part of the FDA approval process for biosimilars.
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