Distinct Therapeutic Choices

When launched, each biosimilar will represent a distinct therapeutic choice and come to market with a unique data package, approved indications, and routes of administration.1

In evaluating the distinct choices biosimilars represent, it is imperative for health care 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 practices.

References: 1. US Food and Drug Administration. Guidance for Industry: Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. www.fda.gov/downloads/drugs/guidance/compliance/regulatory/information/guidances/ucm444661.pdf. Accessed January 10, 2019.