Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this month.

FDA committee recommends Sandoz biosimilar for approval

If approved by the agency, Sandoz will market the biosimilar under the name ZARXIO.

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. 

Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences
Break out of the ordinary: see what’s new in life sciences packaging
At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us this month to experience a breakthrough for life sciences products.
REGISTER NOW!
Break out of the ordinary: see what’s new in life sciences packaging