Rheum360: Focus on Biosimilars
This activity is supported by an independent medical education grant from Sandoz Inc., a Novartis Division.
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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.
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.