Rheum360: Focus on Biosimilars

Pretest

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Question 1
Which of the following statements is false regarding biosimilars?
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Correct answer: D

Rationale: The first 3 statements are true regarding biosimilars. The last statement is false because biosimilars must match the efficacy of the original biologic, not exceed it.

Question 2
How did adalimumab-adaz compare to adalimumab in a phase 3 clinical trial that evaluated efficacy using the Psoriasis Area and Severity Index 75 (PASI 75) as well as safety?
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Correct answer: A

Rationale: Adalimumab-adaz was FDA approved in late October 2018 due to its similar efficacy and safety compared with adalimumab in a phase 3 clinical trial. With biosimilars, efficacy and safety need only to be similar, not superior, to the reference product for approval.

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