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Clin Cancer Res. 2016 Nov 1;22(21):5167-5170. Epub 2016 Aug 31.

Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study.

Author information

1
Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. kun.he@fda.hhs.gov.
2
Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
3
Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Abstract

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) established an abbreviated approval pathway for biosimilar and interchangeable biological products that was intended to balance innovation and consumer interests. The FDA has published several guidance documents to facilitate implementation of the BPCI Act. Here we discuss the role of comparative clinical studies in the assessment of clinically meaningful differences and illustrate the underlying scientific concepts with a hypothetical example of a clinical study comparing a product to US-licensed bevacizumab. Clin Cancer Res; 22(21); 5167-70.

PMID:
27582485
DOI:
10.1158/1078-0432.CCR-16-1010
[Indexed for MEDLINE]
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