Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 is a revised draft guidance for industry similar in scope and format to the final guidance (Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009). It describes the FDA’s current interpretation of pending questions about the following topics:

• Biosimilarity or interchangeability. FDA has not released specific guidance on interchangeability and this is noted in this document.
• Provisions related to requirement to submit a biologics license application for a “biological product.”
• Exclusivity.

FDA intends to update this guidance to include additional questions and answers as appropriate. The current version of the document is available on the Federal Register website.