FDA Advisory Committee Recommends Sandoz’s Biosimilar Filgrastim for ApprovalBy
Sandoz, a Novartis company, reports that the 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 lablel of the reference product, 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 and oncology injectables development at Sandoz, in a company release. “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 nonclinical, clinical, and post-marketing pharmacovigilance data which confirmed Sandoz’ biosimilar filgrastim is highly similar to the reference product, Amgen’s Neupogen, said Novartis in its release. The clinical package included a pharmacokinetic and pharmacodynamics (PK/PD) study in healthy volunteers, which established bioequivalence, and a clinical efficacy and safety study in breast-cancer patients which demonstrated the same clinical performance and safety as the reference product. The clinical package is also supported by a global program including five randomized, double-blind, single and multiple dose PK/PD studies in healthy volunteers to assess pharmacokinetic and pharmacodynamic equivalence between biosimilar filgrastim and Neupogen and a European non-comparative clinical safety and efficacy study. Post-marketing pharmacovigilance data from countries outside of the US also contributed to the totality of evidence.
Sandoz is marketing its biosimilar filgrastim under the brand name Zarzio. It is now marketed in more than 40 countries outside the US. If approved in the US, Sandoz plans to use the same proprietary name.