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GUIDANCE DOCUMENT

Labeling for Biosimilar Products Guidance for Industry July 2018

Final

This guidance is being distributed for comment purposes only.

Docket Number:
2018-15391
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to help applicants develop draft labeling for proposed biosimilar products for submission in an application under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except in for certain recommendations in section V pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). 
 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2018-15391.