Sandoz is the first company to receive the approval of a biosimilar in the US through the new FDA biosimilars pathway established under Biologics Price Competition and Innovation Act (BPCIA), that provides an abbreviated route for biosimilar products to enter the market.
Zarxio (filgrastim-sndz) is designated for all indications included in the reference product’s label. 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 reference product. The approval of Zarxio follows the unanimous positive vote in January by the Oncologic Drugs Advisory Committee (ODAC).
Carol Lynch, Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz, stated: “The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia.