title: Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study.
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. ©2016 AACR.
authors: Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. kun.he@fda.hhs.gov.
authors: Kun
authors: K
authors: He
authors: Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Huanyu
authors: H
authors: Chen
authors: Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Thomas
authors: T
authors: Gwise
authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Sandra
authors: S
authors: Casak
authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Steven
authors: S
authors: Lemery
authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Patricia
authors: P
authors: Keegan
authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Richard
authors: R
authors: Pazdur
authors: Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Rajeshwari
authors: R
authors: Sridhara
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D017277:Drug Approval / Q000706:statistics & numerical data; D006801:Humans; D008495:Medical Oncology / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D059451:Biosimilar Pharmaceuticals