Considerations in Demonstrating Interchangeability With a Reference Product
Consultation Deadline: 20th March, 2017
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product.”
This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product (proposed interchangeable product or proposed product) is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act).
This guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)
Considerations in Demonstrating Interchangeability With a Reference Product