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Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars

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As more biosimilars become available in the United States, postapproval noninterventional studies describing biosimilar switching and comparing effectiveness and/or safety between switchers and nonswitchers will play a key role in… Click to show full abstract

As more biosimilars become available in the United States, postapproval noninterventional studies describing biosimilar switching and comparing effectiveness and/or safety between switchers and nonswitchers will play a key role in generating real‐world evidence to inform clinical practices and policy decisions. Ensuring sound methodology is critical for making valid inferences from these studies.

Keywords: studies switching; reference biologic; noninterventional studies; switching reference; methodologic considerations; considerations noninterventional

Journal Title: Pharmacoepidemiology and Drug Safety
Year Published: 2019

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