Sandoz' Neupogen biosimilar backed by FDA advisory panel

As was largely expected following positive briefing papers earlier this week, the US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC), in a unanimous vote, recommended approval of Swiss pharma giant Novartis’ (NOVN: VX) generics subsidiary Sandoz’ investigational biosimilar filgrastim - used to help cancer patients fight off infection while undergoing chemotherapy - in the USA.

The Committee also recommended approval of the biosimilar for use in all indications included in the label of the reference product, US biotech major Amgen's (Nasdaq: AMGN) blockbuster Neupogen. Assuming that the FDA agrees with the recommendation, this would become the first biosimilar to be approved by the agency.

Under the brand name Zarzio, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the USA, generating nearly 7.5 million patient-exposure days of experience. It was approved in Europe in 2009. If approved in the USA, Sandoz proposes to market biosimilar filgrastim under the name Zarxio.