GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 6 / Year 2017 / Issue 3
Special Report
Physician associations comment on FDA’s interchangeability guidance
Author(s): GaBI Journal Editor
Page: 120-1Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper. Various issues were discussed; this paper highlights the comments on extrapolation, interchangeability, switching, labelling and naming, post-marketing and disease experts. Submitted: 2 June 2017; Revised: 13 June 2017; Accepted: 13 June 2017; […]
