When launched, each biosimilar will represent a distinct therapeutic choice and come to market with a unique data package, approved indications, and similar routes of administration to their reference product.1
In evaluating the distinct choices biosimilars represent, it is imperative for healthcare providers to understand key usage concepts and the unique aspects of each biosimilar—from functional analyses to clinical similarity data—to ensure safe, effective prescribing and use.
Reference: 1. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed October 29, 2019.