Updated on 8 January 2015
Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside US
Singapore: Biopharmaceutical company, Sandoz, has recieved US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of its investigational biosimilar filgrastim in the US.
"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 Mr Mark McCamish, head, global biopharmaceutical and 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."
The recommendation was provided after the presentation of a comprehensive package of nonclinical, clinical and post-marketing pharmacovigilance data which confirmed Sandoz' biosimilar filgrastim is highly similar to the reference product (Amgen's NEUPOGEN).
Under the brand name ZARZIO, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the US, generating nearly 7.5 million patient-exposure days of experience. If approved in the US, Sandoz proposes to market biosimilar filgrastim under the name ZARXIOTM.