Sandoz launches Zarxio (filgrastim-sndz) first biosimilar FDA approved in the US to treat neutropenia

Sandoz, a Novartis company, announced that Zarxio (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar approved by the FDA and the first to launch in the USA. The launch follows the FDA approval of Zarxio on 6 March 2015. The approval, via the new biosimilars pathway established under the Biologics Price Competition and Innovation Act, was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio is highly similar with no clinically meaningful differences to the US-licensed reference product. The successful Sandoz pivotal head-to-head PIONEER study was the final piece of data contributing to the totality of evidence used by FDA to approve Zarxio as biosimilar to the reference product. Importantly, the data demonstrating high similarity was sufficient to allow extrapolation of use of Zarxio to five indications of the reference product.

Comment: Zarxio was approved as Zarzio by the EMA in 2009.