FDA Issues Long-Awaited Biosimilar Interchangeability Guidance
By Michael Mezher -
Published 17 January 2017
The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.
Categories: News, US, FDA, Biologics and biotechnology, Clinical, Postmarket surveillance, Preclinical, Submission and registration
Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study