Sandoz biosimilar filgrastim recommended for approval by FDA Oncologic Drugs Advisory Committee

January 8, 2015 10:56 AM

Sandoz, a Novartis company, announced 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®) 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.”

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. The pivotal 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.

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.

FDA frequently seeks the advice of its advisory committees as it reviews and decides whether to approve treatments, although it is not obligated to follow the recommendation.

 

Source: Sandoz press release

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