The U.S. is inching closer to approving its first biosimilar.
The FDA's Oncologic Drugs Advisory Committee unanimously recommended the approval of Sandoz' biosimilar that is comparable to Amgen's Neupogen.
"We are pleased with the ODAC's recommendation to approve our biosimilar filgrastim and we look forward to continuing to work with FDA as it completes its review of our filing," said Mark McCamish, M.D., Ph.D., Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz, in a news release.
The decision came after recent documents from FDA reviewers decided that there are "no clinically meaningful difference" between Amgen's Neupogen, and Sandoz's biosimilar version.
If approved in the U.S., Sandoz proposes to market the biosimilar under the name ZARXIO.
The drug is used during chemotherapy to fight off infections.
Sandoz is a Novartis company.
