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
Because of the distinct choices biosimilars represent, it is imperative for health care providers to understand key usage concepts and the unique aspects of each biosimilar, including functional data and/or clinical data,
to ensure safe, effective prescribing and use practices.
Reference: 1. US Food and Drug Administration. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: Guidance for Industry. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444661.pdf.
Accessed April 25, 2018.