> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Biosimilar Labeling Guidance Out
- URL: https://www.fdaweb.com/draft-biosimilar-labeling-guidance-out/
- Published: 2016-03-31T12:00:00.000Z
- Updated: 2026-09-14T20:52:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135237

> FDA has published a draft guidance, *Labeling for Biosimilar Products*, to assist applicants in developing draft labeling for submission in applications for proposed biosimilar products. The recommendations for prescription drug labeling in the [document](http://www.fda.gov/downloads/GuidanceComplianceRegulatoryInformation/Guidances/UCM493439.pdf?ref=fdaweb.com) pertain only to the package insert, except for recommendations that pertain to FDA-approved patient labeling such as patient information, Medication Guides, and instructions for use. It does not provide specific labeling recommendations for interchangeable biological products.  
>  
> The guidance includes general principles for draft labeling of proposed biosimilar products, specific recommendations on content of biosimilar product labeling, FDA-approved patient labeling, revising biosimilar product labeling, instructions for submitting initial and revised labeling, and a discussion about interchangeable biological products.