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The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.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Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study
FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance
By Zachary Brennan -
Published 22 September 2016
Although the Food and Drug Administration (FDA) has continued to say that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017.
Categories: News, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration
Tags: biosimilar, interchangeability, BsUFA
In Major Move on Biosimilar Interchangeability, FDA Establishes New 'Purple Book'
By Alexander Gaffney, RAC -
Published 09 September 2014
In a landmark move, the US Food and Drug Administration (FDA) has published its first-ever edition of the "Purple Book," a new list of licensed biological products and interchangeable biosimilars that is meant to be the biological equivalent of the pharmaceutical "Orange Book."
Categories: News, US, CBER, CDER, Biologics and biotechnology, Labeling, Regulatory strategy
Tags: Purple Book, Orange Book, Biosimilarity, Biosimilar, Biosimilars, Interchangeability, Biosimilar Interchangeability