Clinical Trials: Nursing Roles During the Approval Process and Pharmacovigilance of Biosimilars

Jazel Dolores Sugay, MSN, RN


Background: The development of biosimilars is occurring more rapidly as patents on biologics expire. Oncology nurses will have an integral role in the new era of biosimilars regarding administration and education.

Objectives: The purpose of this article is to review the role of the oncology nurse during biosimilar clinical trials, including regulatory guidelines, comparability exercise, clinical trial designs, and extrapolation of clinical trial data. This article also reviews pharmacovigilance.

Methods: A literature search was performed using various databases, and U.S. regulatory agency websites were searched for guidelines.

Findings: The role of the oncology nurse during biosimilar clinical trials includes assessment, monitoring, and reporting of adverse drug reactions associated with a biosimilar. Oncology nurses have key roles in pharmacovigilance of biosimilars, particularly in tracing, monitoring, and accurate reporting of adverse events associated with a specific biosimilar. Oncology nurses and patients must be educated on the proper reporting of adverse events.

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