ODAC Recommends First Biosimliar for Approval to the FDA

The investigational drug by Sandoz, filgrastim, a biological similar to Amgen's Neupogen, is already approved for use in more than 40 countries worldwide.

Sandoz, a Novartis company, announced today that US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of its investigational biosimilar filgrastim in the US. The Committee also recommended approval of the biosimilar for use in all indications included in the reference product's (Amgen's NEUPOGEN(R) ) label.

"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. "We are proud to lead the way in biosimilars globally and believe this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the US."

Link to the Sandoz press release: http://bit.ly/1BMMIs0