This guidance provides answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance revises the 2012 draft guidance on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 to provide new and revised questions and answers. It also includes certain original questions and answers that have not yet been finalized. The questions and answers (Q&As) are grouped below in the following categories:

 

  • Biosimilarity or Interchangeability
  • Provisions Related to Requirement to Submit a BLA for a “Biological Product”
  • Exclusivity

 

 

Posted on the FDA website on 12 May 2015