Abstract:
The Opinion published in this issue of GaBI Journal titled ‘Biosimilars drug development: time for a paradigm shift?’ by Sandeep N Athalye, Shivani Mittra, and Ankitkumar M Ranpur proposes  a number of changes to the regulatory processes currently  in place for biosimilars. This response letter considers the implications and consequences of these.

Subscribe now to GaBI Journal to view full information of this article to be published in the next journal issue.

This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.