Interchangeability Of Biological Drug Products—FDA Draft Guidance. Issue 6 (2nd November 2019)

• Record Type: Journal Article
• Authors: Endrenyi, Laszlo; Markus, Richard
• Is Part Of: Journal of biopharmaceutical statistics. Volume 29:Issue 6(2019)
• Page Start: 1003
• Page End: 1010
• Publication Date: 2019-11-02
• Subjects: Interchangeability -- biosimilars -- switching -- alternation -- substitution; Pharmacy -- Statistical methods -- Periodicals; Drugs -- Testing -- Statistical methods -- Periodicals; Biometry -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacokinetics -- Periodicals; 615.19
• DOI: 10.1080/10543406.2019.1607369
• Languages: English
• ISSNs: 1054-3406

Abstract

ABSTRACT: The Biological Price Competition and Innovation Act (BPCI Act) of 2009 established a pathway for the approval of biosimilars and interchangeable biosimilars in the United States. The Food Drug Administration (FDA) has issued several guidances on the development and assessment of biosimilars which implement the BPCI Act. In particular, a recent draft guidance on the interchangeability of biological products presents an overview of scientific considerations on the demonstration of interchangeability with a reference product. The present communication provides a general summary of the draft guidance and briefly observes a few current issues on interchangeability.