GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 5 / Year 2016 / Issue 3
Meeting Report
Demonstrating interchangeability and biosimilarity for US biosimilars
Author(s): GaBI Journal Editor
Page: 139Abstract: The US Food and Drug Administration (FDA) outlines its approach to biosimilarity and interchangeability at the 2016 Generic Pharmaceutical Association Biosimilars Council Conference. Topics covered include the FDA definition of biosimilarity, its step-wise approach to the approval process and factors/issues that should be considered when providing scientific justification for extrapolation. Submitted: 22 September 2016; […]
First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, 2–3 March 2016, Ankara, Turkey
Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath
Page: 134-8Abstract: This paper discusses the findings and summary of items covered in the First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, in which structure–function was highlighted as a key issue. Submitted: 4 June 2016; Revised: 7 September 2016; Accepted: 15 September 2016; Published online first: 28 September 2016 Introduction This interactive […]
