Sandoz, a Novartis company and a global leader in generic pharmaceuticals launch of first biosimilar Zarxio (filgrastim-sndz). Zarxio is the first biosimilar approved by the US Food and Drug Administration (FDA).
The launch follows the FDA approval of Zarxio on March 6, 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.
Sandoz has a leading pipeline with several biosimilars across the various stages of development, including five programmes in phase III clinical trials/filing preparation.
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