US FDA's 1st biosimilar advisory committee meeting: a lovefest
This article was originally published in SRA
Executive Summary
From the outset, the 7 January meeting of the Food and Drug Administration's oncologic drugs advisory committee (ODAC) was a lovefest between regulators and the filgrastim biosimilar from Novartis and its Sandoz unit. Known under the brand name Zarxio, the product won the panel's unanimous support1,2.