Sandoz First Company to File for Biosimilar Approval in US Under New Pathway
By Alexander Gaffney, RAC -
Published 24 July 2014
Biopharmaceutical company Sandoz, a Novartis subsidiary, has announced that it has filed the first-ever biosimilar application in the US with the Food and Drug Administration (FDA) using its 351(k) pathway.
Categories: News, US, CDER, Biologics and biotechnology, Submission and registration
Tags: Biosimilar, Biosimilarity, Follow-on Biologic, Sandoz, 351(k), First Biosimilar Filing in US