GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 9 / Year 2020 / Issue 4
Commentary
A white paper: US biosimilars market on pace with Europe
Author(s): Madelaine A Feldman, MD, FACR, Michael S Reilly, Esq
Page: 150-4Abstract: In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed. Submitted: 12 October 2020; Revised: 28 October 2020; Accepted: […]
