Sandoz biosimilar filgrastim recommended for approval in the USA

By William Chin, PhD, Scientific Coordinator, EUCRAF

Sandoz announced that US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of its investigational biosimilar filgrastim in the US. The recommended approval of the biosimilar is valid for all indications included in the reference product's (Amgen's NEUPOGEN®) label. Sandoz's presentation of a comprehensive package of nonclinical, clinical (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) and post-marketing pharmacovigilance data was the key success of demonstrating similarity between Sandoz' biosimilar filgrastim and the reference product NEUPOGEN®. In addition, the clinical package contained a global program including five randomized, double-blind, single and multiple dose PK/PD studies in healthy volunteers to assess PK/PD 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 biosimilar filgrastim has been marketed under the brand name ZARZIO® in more than 40 countries outside the US. If approved in the US, Sandoz proposes to market biosimilar filgrastim under the name ZARXIO (TM).


1. Sandoz Media Release, 7 January 2015