Posted by Michael Wonder on 12 Sep 2017
FDA accepts Adello’s biosimilar biologics license application for a proposed filgrastim biosimilar
11 September 2017 - U.S.-based Adello Biologics today announced that U.S. FDA has accepted for review the company’s biologics license application for a biosimilar candidate referencing Neupogen (filgrastim).
The submission is supported by similarity data from analytical, pre-clinical and clinical development studies, comparing the biosimilar candidate to Neupogen.
