Approval Process: An Overview of Biosimilars in the Oncology Setting.

This article aims to describe the approval process of biosimilars, including extrapolation, and to help healthcare providers understand when a biosimilar may be interchanged for the reference biologic and the naming convention used for biosimilars. In addition, this article explores how these topics affect confidence in dispensing and pharmacovigilance. METHODS: A literature review was conducted, and search terms and variation included biosimilar agents AND FDA approval, legislation, interchangeability, naming conventions, confidence in dispensing, and pharmacovigilance. FINDINGS: Healthcare providers involved in the dispensing and administration of biosimilar and interchangeable biologics need to be continually educated to ensure confidence, familiarity, and accuracy with the processes surrounding biosimilars. PMID: 30239527 [PubMed - in process]
Source: Clinical Journal of Oncology Nursing - Category: Nursing Authors: Tags: Clin J Oncol Nurs Source Type: research