CDER SBIA Update: FDA Releases Draft Guidance for Industry: Labeling for Biosimilar Products

FDA Releases Draft Guidance for Industry: Labeling for Biosimilar Products

Today, FDA released draft guidance for industry “Labeling for Biosimilar Products.” This guidance provides an overview of FDA’s recommendations for biosimilar product labeling and is intended to assist industry in developing draft labeling for submission in proposed biosimilar product applications.  A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.  The approval pathway for biosimilar products was established by the Biologics Price Competition and Innovation Act of 2009, which was enacted as part of the Affordable Care Act in March 2010. 

FDA also released a CDER From Our Perspective by Leah Christl describing aspects of this draft guidance.

The Notice of Availability will post the week of April 4^th, 2016 in the Federal Register and will provide information on how to submit comments on this draft guidance.