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GUIDANCE DOCUMENT

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product April 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0605
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.” This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application through an abbreviated licensure pathway. This guidance gives an overview of FDA's approach to determining biosimilarity.

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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: FDA-2011-D-0605.

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