FDA approves Zarxio biosimilar for all filgrastim indications- Sandoz

Sandoz, a Novartis company, announced that the FDA approved Zarxio (filgrastim-sndz) (Zarzio in EU) for all indications included in the reference product's label. Sandoz is the first company to receive approval of a biosimilar in the US 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 reference product. The approval of Zarxio follows the unanimous positive vote in January by the Oncologic Drugs Advisory Committee (ODAC).