Sandoz application for biosimilar Neupogen accepted by US FDA

The US Food and Drug Administration has accepted the 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), by Sandoz, the generics business of Swiss pharma major Novartis (NOVN: VX).

Sandoz is the first company to use this biosimilars approval pathway in the USA, where a formal regulatory system for clearing biological drug follow-ons has yet to be established, as has long been the case n Europe.

The reference product - Amgen's (Nasdaq: AMGN) Neupogen - is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. Neupogen generated sales of $1.4 billion for Amgen last year.