Sandoz's Zarxio first biosimilar to be approved under new FDA pathway

Sandoz, the generics unit of Swiss pharma giant Novartis (NOVN: VX), today received approval from the US Food and Drug Administration for its biosimilar drug Zarxio (filgrastim-sndz) for all indications included in the label of the reference product, Amgen's (Nasdaq: AMGN) Neupogen, which generated $1.2 billion in sales last year.

Sandoz is the first company to receive approval of a biosimilar in the USA through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. The approval was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio is highly similar to the US-licensed Neupogen. The approval of Zarxio follows the unanimous positive vote in January by the Oncologic Drugs Advisory Committee (ODAC).

"The FDA approval of Zarxio marks a significant milestone for the United States health care system and for patients who might suffer from neutropenia," said Carol Lynch, global head of Biopharmaceuticals & Oncology Injectables at Sandoz, adding: "As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the USA."