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FDA Panel Unanimously Backs Neupogen Biosimilar

Advisors recommend approval for all Neupogen indications

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval of the investigational biosimilar filgrastim (Sandoz/Novartis) in the U.S. The committee also recommended approval of the biosimilar for use in all indications included in the label for the reference product, Neupogen (Amgen).

The recommendation was provided after the presentation of a package of nonclinical, clinical, and post-marketing pharmacovigilance data, which showed that biosimilar filgrastim is highly similar to Neupogen. The clinical package included a pharmacokinetics and pharmacodynamics (PK/PD) study in healthy volunteers, which established bioequivalence with Neupogen, and a clinical efficacy and safety study in breast cancer patients, which demonstrated the same clinical performance and safety as that of Neupogen.

The clinical package was also supported by a global program that included five randomized, double-blind, single- and multiple-dose PK/PD studies in healthy volunteers conducted to assess PK and PD equivalence between biosimilar filgrastim and Neupogen. Post-marketing pharmacovigilance data from countries outside of the U.S. also contributed to the evidence.

The biosimilar filgrastim developed by Sandoz/Novartis has been marketed in more than 40 countries outside the U.S. under the brand name Zarzio, accruing nearly 7.5 million patient-exposure days of experience. If approved in the U.S., the biosimilar filgrastim is expected to be marketed under the brand name Zarxio.

The FDA often seeks the advice of its advisory committees as it reviews treatments and decides whether to approve them, although it is not obligated to follow their recommendations.

Source: Sandoz; January 7, 2014.


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