The FDA Releases Guidance on Interchangeability
Mar 9th, 2017 by Nicholas Vincent | News | Recent News & Articles |
In January, the United States Food and Drug Administration (FDA) released a draft guidance entitled, “Considerations in Demonstrating Interchangeability” aimed at helping to implement the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This guidance serves to directly address the issue of demonstrating interchangeability of biological products and the standards required to do so. Interestingly, no product has yet been shown to be interchangeable, including the four biosimiliars that have already been approved by the FDA.