Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review.
Dr. Reddy’s Laboratories announced that its biologics license application for its proposed biosimilar rituximab candidate has been accepted for a substantive review by the US FDA.
