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GUIDANCE DOCUMENT

Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product December 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-0234
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” This guidance is to assist the pharmaceutical industry and other investigators engaged in biosimilar product development in determining the clinical pharmacology data necessary for evaluation of a proposed biosimilar product. This guidance finalizes the draft guidance with the same name issued in May 2014. This guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

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

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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-2014-D-0234.

 
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