Biosimilars according to Jordan Food and Drug Administration regulations.

Authors :: Abdelaziz AA
Source :: Annales pharmaceutiques francaises [Ann Pharm Fr] 2022 May; Vol. 80 (3), pp. 248-252. Date of Electronic Publication: 2021 Oct 29.
Publication Year :: 2022
Abstract: In 2015, JFDA approved its biosimilars registration guidelines [1] officially. Many steps have been taken before achieving this progress. This paper summarizes briefly JFDA efforts that were done in the previous years and the actions taken to approve JFDA biosimilars registration guidance which was based on EMA related guidelines [2-5], and its impact on enhancing the affordability of safe, effective and high quality biosimilars for patients.<br /> (Copyright © 2021 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)