Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
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Guidance Issuing OfficeCenter 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.
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:
Division of Dockets Management (HFA- 305)
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.