Sandoz files Zarzio biosimilar for Neutropenia at FDA.

Sandoz announced that the FDA has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA)

The reference product - Amgen's Neupogen - is indicated to decrease the incidence of infection, as manifested by febrile Neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. Under the brand name Zarzio, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the US, generating nearly six million patient-exposure days of experience. Zarzio is the number one biosimilar filgrastim globally and is the leading daily G-CSF in Europe with 30 percent volume market share.